ID

18153

Beschrijving

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

Trefwoorden

  1. 07-10-16 07-10-16 -
  2. 10-10-16 10-10-16 -
  3. 11-10-16 11-10-16 -
  4. 17-10-16 17-10-16 -
  5. 18-10-16 18-10-16 -
  6. 21-10-16 21-10-16 -
  7. 23-10-16 23-10-16 -
  8. 24-10-16 24-10-16 -
  9. 27-10-16 27-10-16 -
  10. 02-11-16 02-11-16 -
Geüploaded op

24 oktober 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

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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

In-/Exclusion Criteria
Beschrijving

In-/Exclusion Criteria

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

Patient number

Datatype

integer

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

The patient gave his or her consent on

Datatype

text

Maateenheden
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C2985782
YYYY-MM-DD
Are all inclusion criteria fulfilled?
Beschrijving

Are all inclusion criteria fulfilled?

Datatype

integer

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

Are none of the exclusion criteria fulfilled?

Datatype

integer

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

Demographics, Vital Signs and Examinations

Alias
UMLS CUI-1
C1955348
UMLS CUI-2
C0518766
UMLS CUI-3
C0582103
Date of Screening
Beschrijving

Itemgroup: Date of Screening

Datatype

text

Maateenheden
  • YYYY-MM-DD
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1710477
YYYY-MM-DD
Date of Birth
Beschrijving

Sub-Itemgroup: Demographics

Datatype

text

Maateenheden
  • YYYY-MM
Alias
UMLS CUI [1]
C0421451
YYYY-MM
Sex
Beschrijving

Sex

Datatype

integer

Alias
UMLS CUI [1]
C0079399
Nationality
Beschrijving

Sub-Itemgroup: Demographics

Datatype

integer

Alias
UMLS CUI [1]
C0027473
specify nationality
Beschrijving

Sub-Itemgroup: Demographics

Datatype

text

Alias
UMLS CUI [1]
C0027473
Height
Beschrijving

Sub-Itemgroup: Demographics

Datatype

float

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschrijving

Sub-Itemgroup: Demographics

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
LDH
Beschrijving

Sub-Itemgroup: Demographics

Datatype

float

Maateenheden
  • U/l
Alias
UMLS CUI [1]
C0202113
U/l
1. Systolic blood pressure
Beschrijving

Sub-Itemgroup: Vital Signs

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
1. Diastolic blood pressure
Beschrijving

Sub-Itemgroup: Vital Signs

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
2. Systolic blood pressure
Beschrijving

Sub-Itemgroup: Vital Signs

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
2. Diastolic blood pressure
Beschrijving

Sub-Itemgroup: Vital Signs

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
3. Systolic blood pressure
Beschrijving

Sub-Itemgroup: Vital Signs

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
3. Diastolic blood pressure
Beschrijving

Sub-Itemgroup: Vital Signs

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Sitting heart rate
Beschrijving

Sub-Itemgroup: Vital Signs

Datatype

integer

Maateenheden
  • beats per minute
Alias
UMLS CUI [1]
C2029904
beats per minute
Body temperature
Beschrijving

Sub-Itemgroup: Vital Signs

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Physical examination
Beschrijving

Sub-Itemgroup: Examinations

Datatype

integer

Alias
UMLS CUI [1]
C0031809
Abdominal ultrasound
Beschrijving

Sub-Itemgroup: Examinations

Datatype

integer

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

Sub-Itemgroup: Examinations

Datatype

integer

Alias
UMLS CUI [1]
C0430456
Bone marrow
Beschrijving

Sub-Itemgroup: Examinations

Datatype

integer

Alias
UMLS CUI [1]
C0005957
Walk distance
Beschrijving

Sub-Itemgroup: Six-Minute Walk Test

Datatype

integer

Maateenheden
  • Meter
Alias
UMLS CUI [1]
C3854161
Meter
Does the patient report symptoms of dyspnea?
Beschrijving

Sub-Itemgroup: Six-Minute Walk Test

Datatype

integer

Alias
UMLS CUI [1]
C0013404
Circulatory Symptoms
Beschrijving

Circulatory Symptoms

Alias
UMLS CUI-1
C0476270
Date of first Cold Agglutin Disease diagnosis
Beschrijving

Date of first Cold Agglutin Disease

Datatype

date

Maateenheden
  • YYYY-MM-DD
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0175816
YYYY-MM-DD
Thrombophlebitis/Deep Vein Thrombosis
Beschrijving

Thrombophlebitis/Deep Vein Thrombosis

Datatype

integer

Alias
UMLS CUI [1]
C0040046
UMLS CUI [2]
C0149871
Pulmonary Embolus
Beschrijving

Pulmonary Embolus

Datatype

integer

Alias
UMLS CUI [1]
C0034065
Cerebrovascular Accident
Beschrijving

Cerebrovascular Accident

Datatype

integer

Alias
UMLS CUI [1]
C0038454
Amputation
Beschrijving

Amputation

Datatype

integer

Alias
UMLS CUI [1]
C0002688
Myocardial Infarction
Beschrijving

Myocardial Infarction

Datatype

integer

Alias
UMLS CUI [1]
C0027051
Transient Ischemic Attack
Beschrijving

Transient Ischemic Attack

Datatype

integer

Alias
UMLS CUI [1]
C0007787
Unstable Angina
Beschrijving

Unstable Angina

Datatype

integer

Alias
UMLS CUI [1]
C0002965
Renal Vein Thrombosis
Beschrijving

Renal Vein Thrombosis

Datatype

integer

Alias
UMLS CUI [1]
C0238457
Mesenteric Vein Thrombosis
Beschrijving

Mesenteric Vein Thrombosis

Datatype

integer

Alias
UMLS CUI [1]
C0267412
Portal Vein Thrombosis (Budd-Chiari)
Beschrijving

Portal Vein Thrombosis (Budd-Chiari)

Datatype

integer

Alias
UMLS CUI [1]
C0155773
Gangrene
Beschrijving

Gangrene

Datatype

integer

Alias
UMLS CUI [1]
C0017086
Acute Peripheral Vascular Occlusion
Beschrijving

Acute Peripheral Vascular Occlusion

Datatype

integer

Alias
UMLS CUI [1]
C0240728
Sudden Death
Beschrijving

Sudden Death

Datatype

integer

Alias
UMLS CUI [1]
C0011071
Patient suffers from other accompanying illnesses?
Beschrijving

Patient suffers from other accompanying illnesses?

Datatype

integer

Alias
UMLS CUI [1]
C0009488
Only for Woman (under 50): Is the pregnancy test negativ?
Beschrijving

Only for Woman (under 50): Is the pregnancy test negativ?

Datatype

integer

Alias
UMLS CUI [1]
C0032976
Comments
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
Signature date
Beschrijving

Sub-Itemgroup: Investigator's signature

Datatype

date

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

Sub-Itemgroup: Investigator's signature

Datatype

integer

Alias
UMLS CUI [1]
C2346576
One year transfusion history
Beschrijving

One year transfusion history

Alias
UMLS CUI-1
C1519604
Date of blood transfusion
Beschrijving

Date of blood transfusion

Datatype

date

Maateenheden
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C1264703
YYYY-MM-DD
Number of units
Beschrijving

Number of units

Datatype

integer

Alias
UMLS CUI [1,1]
C0086252
UMLS CUI [1,2]
C0449961
Hemoglobin before transfusion
Beschrijving

Hemoglobin before transfusion

Datatype

float

Maateenheden
  • ulHGB
Alias
UMLS CUI [1]
C0518015
ulHGB
Hemoglobin before transfusion
Beschrijving

Hemoglobin before transfusion2

Datatype

integer

Maateenheden
  • ulHGB
Alias
UMLS CUI [1]
C0518015
Any special events circumstances transfusion?
Beschrijving

Any special events circumstances transfusion?

Datatype

integer

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

if yes, please specify

Datatype

text

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

Sub-Itemgroup: Investigator's signature

Datatype

date

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

Sub-Itemgroup: Investigator's signature

Datatype

integer

Alias
UMLS CUI [1]
C2346576
Preexisting and concomitant diseases
Beschrijving

Preexisting and concomitant diseases

Alias
UMLS CUI-1
C0243087
The patient has no preexisting/concomitant diseases
Beschrijving

Concomitant disease

Datatype

integer

Alias
UMLS CUI [1]
C0243087
Signature date
Beschrijving

Sub-Itemgroup: Investigator's signature

Datatype

date

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

Sub-Itemgroup: Investigator's signature

Datatype

integer

Alias
UMLS CUI [1]
C2346576
Preexisting and concomitant
Beschrijving

Preexisting and concomitant

Alias
UMLS CUI-1
C0243087
CD No
Beschrijving

CD No

Datatype

text

Description of concomitant diseases
Beschrijving

concomitant diseases

Datatype

text

Alias
UMLS CUI [1]
C0150941
First occurred
Beschrijving

First occurred

Datatype

date

Alias
UMLS CUI [1]
C2316983
Visit 0 - FACIT
Beschrijving

Visit 0 - FACIT

Alias
UMLS CUI-1
C1512346
UMLS CUI-2
C3476791
lack of vitality
Beschrijving

lack of vitality

Datatype

integer

Alias
UMLS CUI [1]
C1337102
nausea
Beschrijving

nausea

Datatype

integer

Alias
UMLS CUI [1]
C0027497
General health deterioration
Beschrijving

General health deterioration

Datatype

integer

Alias
UMLS CUI [1]
C0563273
pain
Beschrijving

pain

Datatype

integer

Alias
UMLS CUI [1]
C0030193
treatment side-effects
Beschrijving

treatment side-effects

Datatype

integer

Alias
UMLS CUI [1]
C0879626
feeling of illness
Beschrijving

feeling of illness

Datatype

integer

Alias
UMLS CUI [1]
C0231218
bedrest
Beschrijving

bedrest

Datatype

integer

Alias
UMLS CUI [1]
C0004910
Freunden nahe
Beschrijving

interacts with close friends

Datatype

integer

Alias
UMLS CUI [1]
C0518615
Family support
Beschrijving

family support

Datatype

integer

Alias
UMLS CUI [1]
C0150232
receives support from friends
Beschrijving

receives support from friends

Datatype

integer

Alias
UMLS CUI [1]
C2984072
accepts disease
Beschrijving

accepts disease

Datatype

integer

satisfied with talking about disease
Beschrijving

satisfied with talking about disease

Datatype

integer

feel close to other people
Beschrijving

feel close to other people

Datatype

integer

Alias
UMLS CUI [1]
C2984048
UMLS CUI [2]
C2984059
satisfied with sex life
Beschrijving

satisfied with sex life

Datatype

integer

Alias
UMLS CUI [1]
C2984060
sadness
Beschrijving

sadness

Datatype

integer

Alias
UMLS CUI [1]
C3827348
satisfied with fighting against the illness
Beschrijving

satisfied with fighting against the illness

Datatype

integer

losing hope
Beschrijving

losing hope

Datatype

integer

Alias
UMLS CUI [1]
C2984056
nervousness
Beschrijving

nervousness

Datatype

integer

Alias
UMLS CUI [1]
C0027769
worries about death
Beschrijving

worries about death

Datatype

integer

Alias
UMLS CUI [1]
C2984076
worries about condition
Beschrijving

worries about condition

Datatype

integer

Alias
UMLS CUI [1]
C2984075
able to work
Beschrijving

able to work

Datatype

integer

Alias
UMLS CUI [1]
C2984044
satisfied with work
Beschrijving

satisfied with work

Datatype

integer

Alias
UMLS CUI [1]
C0578800
able to enjoy life
Beschrijving

able to enjoy life

Datatype

integer

Alias
UMLS CUI [1]
C2984051
cope with disease
Beschrijving

cope with disease

Datatype

integer

Alias
UMLS CUI [1,1]
C0009967
UMLS CUI [1,2]
C0012634
sleeping
Beschrijving

sleeping

Datatype

integer

Alias
UMLS CUI [1]
C0474396
able to enjoy leisure
Beschrijving

able to enjoy leisure

Datatype

integer

Alias
UMLS CUI [1]
C2984052
currently satisfied with life
Beschrijving

currently satisfied with life

Datatype

integer

Alias
UMLS CUI [1]
C1954023
fatigue
Beschrijving

fatigue

Datatype

integer

Alias
UMLS CUI [1]
C0015672
weak
Beschrijving

weak

Datatype

integer

Alias
UMLS CUI [1]
C3714552
listless
Beschrijving

listless

Datatype

integer

Alias
UMLS CUI [1]
C0023380
tired
Beschrijving

tired

Datatype

integer

Alias
UMLS CUI [1]
C0848717
tiredness limiting starting things
Beschrijving

tiredness limiting starting things

Datatype

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0439659
tiredness limits finishing things
Beschrijving

tiredness limits finishing things

Datatype

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C3259534
having energy
Beschrijving

having energy

Datatype

integer

Alias
UMLS CUI [1]
C0542479
able to do usual activities
Beschrijving

able to do usual activities

Datatype

integer

Alias
UMLS CUI [1]
C0441655
sleep during daytime
Beschrijving

sleep during daytime

Datatype

integer

Alias
UMLS CUI [1]
C4075948
too tired to eat
Beschrijving

too tired to eat

Datatype

integer

Alias
UMLS CUI [1]
C3897355
need help with usual activities
Beschrijving

need help with usual activities

Datatype

integer

Alias
UMLS CUI [1]
C3898152
frustrated by fatigue
Beschrijving

frustrated by fatigue

Datatype

integer

Alias
UMLS CUI [1,1]
C0016770
UMLS CUI [1,2]
C0015672
fatigue limiting social activity
Beschrijving

fatigue limiting social activity

Datatype

integer

Alias
UMLS CUI [1]
C3898911
Visit 0 - SF36
Beschrijving

Visit 0 - SF36

Alias
UMLS CUI-1
C1512346
UMLS CUI-2
C3640521
1. In general, would you say your health is:
Beschrijving

general health condition

Datatype

integer

Alias
UMLS CUI [1]
C2964120
2. Compared to one year ago, how would you rate your health in general now?
Beschrijving

current state of health

Datatype

integer

Alias
UMLS CUI [1]
C3534559
3. The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much?
Beschrijving

limited in activities

Datatype

text

a) Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports
Beschrijving

Vigorous activities

Datatype

integer

Alias
UMLS CUI [1]
C3484322
b) Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf
Beschrijving

Moderate activities

Datatype

integer

Alias
UMLS CUI [1]
C3484321
c) Lifting or carrying groceries
Beschrijving

Lifting or carrying groceries

Datatype

integer

Alias
UMLS CUI [1]
C2963469
d) Climbing several flights of stairs
Beschrijving

Climbing several flights of stairs

Datatype

integer

Alias
UMLS CUI [1]
C2963450
e) Climbing one flight of stairs
Beschrijving

Climbing one flight of stairs

Datatype

integer

Alias
UMLS CUI [1]
C2963449
f) Bending, kneeling, or stooping
Beschrijving

Bending, kneeling, or stooping

Datatype

integer

Alias
UMLS CUI [1]
C3484318
g) Walking more than a mile
Beschrijving

Walking more than a mile

Datatype

integer

Alias
UMLS CUI [1]
C2963455
h) Walking several blocks
Beschrijving

Walking several blocks

Datatype

integer

Alias
UMLS CUI [1]
C3484325
i) Walking one block
Beschrijving

Walking one block

Datatype

integer

Alias
UMLS CUI [1]
C3484324
j) Bathing or dressing yourself
Beschrijving

Bathing or dressing yourself

Datatype

integer

Alias
UMLS CUI [1]
C2963459
4. During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health?
Beschrijving

problems in past 4 weeks

Datatype

text

a) Cut down the amount of time you spent on work or other activities
Beschrijving

Cut down the amount of time you spent on work or other activities

Datatype

integer

Alias
UMLS CUI [1]
C3899484
b) Accomplished less than you would like
Beschrijving

Accomplished less than you would like

Datatype

integer

Alias
UMLS CUI [1]
C3900126
c) Were limited in the kind of work or other activities
Beschrijving

Were limited in the kind of work or other activities

Datatype

integer

Alias
UMLS CUI [1]
C3898591
d) Had difficulty performing the work or other activities (for example, it took extra effort)
Beschrijving

Had difficulty performing the work or other activities (for example, it took extra effort)

Datatype

integer

Alias
UMLS CUI [1]
C3898961
5. During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)?
Beschrijving

emotional problems

Datatype

text

a) Cut down the amount of time you spent on work or other activities
Beschrijving

Cut down the amount of time you spent on work or other activities

Datatype

integer

Alias
UMLS CUI [1,1]
C3899484
UMLS CUI [1,2]
C0677660
b) Accomplished less than you would like
Beschrijving

Accomplished less than you would like

Datatype

integer

Alias
UMLS CUI [1]
C3900126
c) Didn't do work or other activities as carefully as usual
Beschrijving

Didnt do work or other activities as carefully as usual

Datatype

integer

Alias
UMLS CUI [1]
C3899381
6. During the past 4 weeks, to what extent has your physical health or emotional problems interfered with your normal social activities with family, friends, neighbors, or groups?
Beschrijving

emotional problems limiting social activities

Datatype

integer

Alias
UMLS CUI [1]
C3484328
7. How much bodily pain have you had during the past 4 weeks?
Beschrijving

bodily pain during the past 4 weeks

Datatype

integer

Alias
UMLS CUI [1]
C3534550
8. During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?
Beschrijving

pain interfere with your normal work

Datatype

integer

Alias
UMLS CUI [1]
C3484326
9. These questions are about how you feel and how things have been with you during the past 4 weeks. For each question, please give the one answer that comes closest to the way you have been feeling.
Beschrijving

feelings last 4 weeks

Datatype

text

a) Did you feel full of pep?
Beschrijving

Did you feel full of pep?

Datatype

integer

Alias
UMLS CUI [1]
C3484313
b) Have you been a very nervous person?
Beschrijving

Have you been a very nervous person?

Datatype

integer

Alias
UMLS CUI [1]
C3475469
c) Have you felt so down in the dumps that nothing could cheer you up?
Beschrijving

Have you felt so down in the dumps that nothing could cheer you up?

Datatype

integer

Alias
UMLS CUI [1]
C3475473
d) Have you felt calm and peaceful?
Beschrijving

Have you felt calm and peaceful?

Datatype

integer

Alias
UMLS CUI [1]
C3475471
e) Did you have a lot of energy?
Beschrijving

Did you have a lot of energy?

Datatype

integer

Alias
UMLS CUI [1]
C3484316
f) Have you felt downhearted and blue?
Beschrijving

Have you felt downhearted and blue?

Datatype

integer

Alias
UMLS CUI [1]
C3475472
g) Did you feel worn out?
Beschrijving

Did you feel worn out?

Datatype

integer

Alias
UMLS CUI [1]
C3484315
h) Have you been a happy person?
Beschrijving

Have you been a happy person?

Datatype

integer

Alias
UMLS CUI [1]
C3475468
i) Did you feel tired?
Beschrijving

Did you feel tired?

Datatype

integer

Alias
UMLS CUI [1]
C3484314
10. 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.)?
Beschrijving

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.)?

Datatype

integer

Alias
UMLS CUI [1]
C3484327
11. How TRUE or FALSE is each of the following statements for you.
Beschrijving

How TRUE or FALSE is each of the following statements for you.

Datatype

text

a) I seem to get sick a little easier than other people
Beschrijving

I seem to get sick a little easier than other people

Datatype

integer

Alias
UMLS CUI [1]
C3899028
b) I am as healthy as anybody I know
Beschrijving

I am as healthy as anybody I know

Datatype

integer

Alias
UMLS CUI [1]
C3900054
c) I expect my health to get worse
Beschrijving

I expect my health to get worse

Datatype

integer

Alias
UMLS CUI [1]
C3475697
d) My health is excellent
Beschrijving

My health is excellent

Datatype

integer

Alias
UMLS CUI [1]
C3476206

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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])
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-2)
C0582103 (UMLS CUI-3)
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])
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Item
Nationality
integer
C0027473 (UMLS CUI [1])
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])
Code List
Physical examination
CL Item
without pathologic findings (0)
CL Item
with pathologic findings (1)
Item
Abdominal ultrasound
integer
C2348813 (UMLS CUI [1])
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])
Code List
12-lead electrocardiogram
CL Item
without pathologic findings , 1=with pathologic findings (0)
CL Item
 (1)
Item
Bone marrow
integer
C0005957 (UMLS CUI [1])
Code List
Bone marrow
CL Item
without pathologic findings  (0)
CL Item
with pathologic findings (1)
Walk distance
Item
Walk distance
integer
C3854161 (UMLS CUI [1])
Item
Does the patient report symptoms of dyspnea?
integer
C0013404 (UMLS CUI [1])
Code List
Does the patient report symptoms of dyspnea?
CL Item
no (0)
CL Item
yes (1)
Item Group
Circulatory Symptoms
C0476270 (UMLS CUI-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])
Item
Thrombophlebitis/Deep Vein Thrombosis
integer
C0040046 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
Code List
Thrombophlebitis/Deep Vein Thrombosis
CL Item
no (0)
CL Item
yes (1)
Item
Pulmonary Embolus
integer
C0034065 (UMLS CUI [1])
Code List
Pulmonary Embolus
CL Item
no (0)
CL Item
yes (1)
Item
Cerebrovascular Accident
integer
C0038454 (UMLS CUI [1])
Code List
Cerebrovascular Accident
CL Item
no (0)
CL Item
yes (1)
Item
Amputation
integer
C0002688 (UMLS CUI [1])
Code List
Amputation
CL Item
no (0)
CL Item
yes (1)
Item
Myocardial Infarction
integer
C0027051 (UMLS CUI [1])
Code List
Myocardial Infarction
CL Item
no (0)
CL Item
yes (1)
Item
Transient Ischemic Attack
integer
C0007787 (UMLS CUI [1])
Code List
Transient Ischemic Attack
CL Item
no (0)
CL Item
yes (1)
Item
Unstable Angina
integer
C0002965 (UMLS CUI [1])
Code List
Unstable Angina
CL Item
no (0)
CL Item
yes (1)
Item
Renal Vein Thrombosis
integer
C0238457 (UMLS CUI [1])
Code List
Renal Vein Thrombosis
CL Item
no (0)
CL Item
yes (1)
Item
Mesenteric Vein Thrombosis
integer
C0267412 (UMLS CUI [1])
Code List
Mesenteric Vein Thrombosis
CL Item
no (0)
CL Item
yes (1)
Item
Portal Vein Thrombosis (Budd-Chiari)
integer
C0155773 (UMLS CUI [1])
Code List
Portal Vein Thrombosis (Budd-Chiari)
CL Item
no (0)
CL Item
yes (1)
Item
Gangrene
integer
C0017086 (UMLS CUI [1])
CL Item
no (0)
CL Item
yes (1)
Item
Acute Peripheral Vascular Occlusion
integer
C0240728 (UMLS CUI [1])
Code List
Acute Peripheral Vascular Occlusion
CL Item
no (0)
CL Item
yes (1)
Item
Sudden Death
integer
C0011071 (UMLS CUI [1])
CL Item
no (0)
CL Item
yes (1)
Item
Patient suffers from other accompanying illnesses?
integer
C0009488 (UMLS CUI [1])
Code List
Patient suffers from other accompanying illnesses?
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])
Item
Investigator's signature
integer
C2346576 (UMLS CUI [1])
Code List
Investigator's signature
CL Item
no (0)
CL Item
yes (1)
Item Group
One year transfusion history
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])
Hemoglobin before transfusion
Item
Hemoglobin before transfusion
float
C0518015 (UMLS CUI [1])
Item
Hemoglobin before transfusion
integer
C0518015 (UMLS CUI [1])
Code List
Hemoglobin before transfusion
CL Item
g/dl (1)
CL Item
mmol/l (2)
Item
Any special events circumstances transfusion?
integer
C0877248 (UMLS CUI [1,1])
C1879316 (UMLS CUI [1,2])
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])
Code List
Investigator's signature
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])
Code List
The patient has no preexisting/concomitant diseases
CL Item
no (0)
CL Item
yes (1)
Signature date
Item
Signature date
date
C0807937 (UMLS CUI [1])
Item
Investigator's signature
integer
C2346576 (UMLS CUI [1])
Code List
Investigator's signature
CL Item
no (0)
CL Item
yes (1)
Item Group
Preexisting and concomitant
C0243087 (UMLS CUI-1)
CD No
Item
text
concomitant diseases
Item
Description of concomitant diseases
text
C0150941 (UMLS CUI [1])
First occurred
Item
First occurred
date
C2316983 (UMLS CUI [1])
Item Group
Visit 0 - FACIT
C1512346 (UMLS CUI-1)
C3476791 (UMLS CUI-2)
Item
lack of vitality
integer
C1337102 (UMLS CUI [1])
Code List
lack of vitality
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
nausea
integer
C0027497 (UMLS CUI [1])
Code List
nausea
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
General health deterioration
integer
C0563273 (UMLS CUI [1])
Code List
General health deterioration
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
pain
integer
C0030193 (UMLS CUI [1])
Code List
pain
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
treatment side-effects
integer
C0879626 (UMLS CUI [1])
Code List
treatment side-effects
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
feeling of illness
integer
C0231218 (UMLS CUI [1])
Code List
feeling of illness
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
bedrest
integer
C0004910 (UMLS CUI [1])
Code List
bedrest
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
Freunden nahe
integer
C0518615 (UMLS CUI [1])
Code List
Freunden nahe
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
Family support
integer
C0150232 (UMLS CUI [1])
Code List
Family support
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
receives support from friends
integer
C2984072 (UMLS CUI [1])
Code List
receives support from friends
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
accepts disease
integer
Code List
accepts disease
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
satisfied with talking about disease
integer
Code List
satisfied with talking about disease
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
feel close to other people
integer
C2984048 (UMLS CUI [1])
C2984059 (UMLS CUI [2])
Code List
feel close to other people
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
satisfied with sex life
integer
C2984060 (UMLS CUI [1])
Code List
satisfied with sex life
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
sadness
integer
C3827348 (UMLS CUI [1])
Code List
sadness
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
satisfied with fighting against the illness
integer
Code List
satisfied with fighting against the illness
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
losing hope
integer
C2984056 (UMLS CUI [1])
Code List
losing hope
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
nervousness
integer
C0027769 (UMLS CUI [1])
Code List
nervousness
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
worries about death
integer
C2984076 (UMLS CUI [1])
Code List
worries about death
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
worries about condition
integer
C2984075 (UMLS CUI [1])
Code List
worries about condition
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
able to work
integer
C2984044 (UMLS CUI [1])
Code List
able to work
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
satisfied with work
integer
C0578800 (UMLS CUI [1])
Code List
satisfied with work
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
able to enjoy life
integer
C2984051 (UMLS CUI [1])
Code List
able to enjoy life
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
cope with disease
integer
C0009967 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Code List
cope with disease
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
sleeping
integer
C0474396 (UMLS CUI [1])
Code List
sleeping
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
able to enjoy leisure
integer
C2984052 (UMLS CUI [1])
Code List
able to enjoy leisure
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
currently satisfied with life
integer
C1954023 (UMLS CUI [1])
Code List
currently satisfied with life
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
fatigue
integer
C0015672 (UMLS CUI [1])
Code List
fatigue
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
weak
integer
C3714552 (UMLS CUI [1])
Code List
weak
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
listless
integer
C0023380 (UMLS CUI [1])
Code List
listless
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
tired
integer
C0848717 (UMLS CUI [1])
Code List
tired
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
tiredness limiting starting things
integer
C0015672 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
Code List
tiredness limiting starting things
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
tiredness limits finishing things
integer
C0015672 (UMLS CUI [1,1])
C3259534 (UMLS CUI [1,2])
Code List
tiredness limits finishing things
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
having energy
integer
C0542479 (UMLS CUI [1])
Code List
having energy
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
able to do usual activities
integer
C0441655 (UMLS CUI [1])
Code List
able to do usual activities
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
sleep during daytime
integer
C4075948 (UMLS CUI [1])
Code List
sleep during daytime
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
too tired to eat
integer
C3897355 (UMLS CUI [1])
Code List
too tired to eat
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
need help with usual activities
integer
C3898152 (UMLS CUI [1])
Code List
need help with usual activities
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
frustrated by fatigue
integer
C0016770 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
Code List
frustrated by fatigue
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item
fatigue limiting social activity
integer
C3898911 (UMLS CUI [1])
Code List
fatigue limiting social activity
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
Item Group
Visit 0 - SF36
C1512346 (UMLS CUI-1)
C3640521 (UMLS CUI-2)
Item
1. In general, would you say your health is:
integer
C2964120 (UMLS CUI [1])
Code List
1. In general, would you say your health is:
CL Item
Excellent (1)
CL Item
Very good (2)
CL Item
Good (3)
CL Item
Fair (4)
CL Item
Poor (5)
Item
2. Compared to one year ago, how would you rate your health in general now?
integer
C3534559 (UMLS CUI [1])
Code List
2. Compared to one year ago, how would you rate your health in general now?
CL Item
Much better now than one year ago  (1)
CL Item
Somewhat better now than one year ago  (2)
CL Item
About the same  (3)
CL Item
Somewhat worse now than one year ago  (4)
CL Item
Much worse now than one year ago (5)
limited in activities
Item
3. The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much?
text
Item
a) Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports
integer
C3484322 (UMLS CUI [1])
Code List
a) Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports
CL Item
Yes, limited a lot  (1)
CL Item
Yes, limited a little  (2)
CL Item
No, not limited at all (3)
Item
b) Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf
integer
C3484321 (UMLS CUI [1])
Code List
b) Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf
CL Item
Yes, limited a lot  (1)
CL Item
Yes, limited a little  (2)
CL Item
No, not limited at all (3)
Item
c) Lifting or carrying groceries
integer
C2963469 (UMLS CUI [1])
Code List
c) Lifting or carrying groceries
CL Item
Yes, limited a lot  (1)
CL Item
Yes, limited a little  (2)
CL Item
No, not limited at all (3)
Item
d) Climbing several flights of stairs
integer
C2963450 (UMLS CUI [1])
Code List
d) Climbing several flights of stairs
CL Item
Yes, limited a lot  (1)
CL Item
Yes, limited a little  (2)
CL Item
No, not limited at all (3)
Item
e) Climbing one flight of stairs
integer
C2963449 (UMLS CUI [1])
Code List
e) Climbing one flight of stairs
CL Item
Yes, limited a lot  (1)
CL Item
Yes, limited a little  (2)
CL Item
No, not limited at all (3)
Item
f) Bending, kneeling, or stooping
integer
C3484318 (UMLS CUI [1])
Code List
f) Bending, kneeling, or stooping
CL Item
Yes, limited a lot  (1)
CL Item
Yes, limited a little  (2)
CL Item
No, not limited at all (3)
Item
g) Walking more than a mile
integer
C2963455 (UMLS CUI [1])
Code List
g) Walking more than a mile
CL Item
Yes, limited a lot  (1)
CL Item
Yes, limited a little  (2)
CL Item
No, not limited at all (3)
Item
h) Walking several blocks
integer
C3484325 (UMLS CUI [1])
Code List
h) Walking several blocks
CL Item
Yes, limited a lot  (1)
CL Item
Yes, limited a little  (2)
CL Item
No, not limited at all (3)
Item
i) Walking one block
integer
C3484324 (UMLS CUI [1])
Code List
i) Walking one block
CL Item
Yes, limited a lot  (1)
CL Item
Yes, limited a little  (2)
CL Item
No, not limited at all (3)
Item
j) Bathing or dressing yourself
integer
C2963459 (UMLS CUI [1])
Code List
j) Bathing or dressing yourself
CL Item
Yes, limited a lot  (1)
CL Item
Yes, limited a little  (2)
CL Item
No, not limited at all (3)
problems in past 4 weeks
Item
4. During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health?
text
Item
a) Cut down the amount of time you spent on work or other activities
integer
C3899484 (UMLS CUI [1])
Code List
a) Cut down the amount of time you spent on work or other activities
CL Item
All of the time  (1)
CL Item
Most of the time  (2)
CL Item
Some of the time  (3)
CL Item
A little of the time  (4)
CL Item
None of the time (5)
Item
b) Accomplished less than you would like
integer
C3900126 (UMLS CUI [1])
Code List
b) Accomplished less than you would like
CL Item
All of the time  (1)
CL Item
Most of the time  (2)
CL Item
Some of the time  (3)
CL Item
A little of the time  (4)
CL Item
None of the time (5)
Item
c) Were limited in the kind of work or other activities
integer
C3898591 (UMLS CUI [1])
Code List
c) Were limited in the kind of work or other activities
CL Item
All of the time  (1)
CL Item
Most of the time  (2)
CL Item
Some of the time  (3)
CL Item
A little of the time  (4)
CL Item
None of the time (5)
Item
d) Had difficulty performing the work or other activities (for example, it took extra effort)
integer
C3898961 (UMLS CUI [1])
Code List
d) Had difficulty performing the work or other activities (for example, it took extra effort)
CL Item
All of the time  (1)
CL Item
Most of the time  (2)
CL Item
Some of the time  (3)
CL Item
A little of the time  (4)
CL Item
None of the time (5)
emotional problems
Item
5. During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)?
text
Item
a) Cut down the amount of time you spent on work or other activities
integer
C3899484 (UMLS CUI [1,1])
C0677660 (UMLS CUI [1,2])
Code List
a) Cut down the amount of time you spent on work or other activities
CL Item
All of the time  (1)
CL Item
Most of the time  (2)
CL Item
Some of the time  (3)
CL Item
A little of the time  (4)
CL Item
None of the time (5)
Item
b) Accomplished less than you would like
integer
C3900126 (UMLS CUI [1])
Code List
b) Accomplished less than you would like
CL Item
All of the time  (1)
CL Item
Most of the time  (2)
CL Item
Some of the time  (3)
CL Item
A little of the time  (4)
CL Item
None of the time (5)
Item
c) Didn't do work or other activities as carefully as usual
integer
C3899381 (UMLS CUI [1])
Code List
c) Didn't do work or other activities as carefully as usual
CL Item
All of the time  (1)
CL Item
Most of the time  (2)
CL Item
Some of the time  (3)
CL Item
A little of the time  (4)
CL Item
None of the time (5)
Item
6. During the past 4 weeks, to what extent has your physical health or emotional problems interfered with your normal social activities with family, friends, neighbors, or groups?
integer
C3484328 (UMLS CUI [1])
Code List
6. During the past 4 weeks, to what extent has your physical health or emotional problems interfered with your normal social activities with family, friends, neighbors, or groups?
CL Item
Not at all (1)
CL Item
Slightly (2)
CL Item
Moderately (3)
CL Item
Quite a bit (4)
CL Item
Extremely (5)
Item
7. How much bodily pain have you had during the past 4 weeks?
integer
C3534550 (UMLS CUI [1])
Code List
7. How much bodily pain have you had during the past 4 weeks?
CL Item
None (1)
CL Item
Very mild (2)
CL Item
Mild (3)
CL Item
Moderate (4)
CL Item
Severe (5)
CL Item
Very severe (6)
Item
8. During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?
integer
C3484326 (UMLS CUI [1])
Code List
8. During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?
CL Item
Not at all (1)
CL Item
A Little bit (2)
CL Item
Moderately (3)
CL Item
 (4)
CL Item
 (5)
feelings last 4 weeks
Item
9. These questions are about how you feel and how things have been with you during the past 4 weeks. For each question, please give the one answer that comes closest to the way you have been feeling.
text
Item
a) Did you feel full of pep?
integer
C3484313 (UMLS CUI [1])
CL Item
All of the time  (1)
CL Item
Most of the time  (2)
CL Item
Some of the time  (3)
CL Item
A little of the time  (4)
CL Item
None of the time (5)
Item
b) Have you been a very nervous person?
integer
C3475469 (UMLS CUI [1])
Code List
b) Have you been a very nervous person?
CL Item
All of the time  (1)
CL Item
Most of the time  (2)
CL Item
Some of the time  (3)
CL Item
A little of the time  (4)
CL Item
None of the time (5)
Item
c) Have you felt so down in the dumps that nothing could cheer you up?
integer
C3475473 (UMLS CUI [1])
Code List
c) Have you felt so down in the dumps that nothing could cheer you up?
CL Item
All of the time  (1)
CL Item
Most of the time  (2)
CL Item
Some of the time  (3)
CL Item
A little of the time  (4)
CL Item
None of the time (5)
Item
d) Have you felt calm and peaceful?
integer
C3475471 (UMLS CUI [1])
Code List
d) Have you felt calm and peaceful?
CL Item
All of the time  (1)
CL Item
Most of the time  (2)
CL Item
Some of the time  (3)
CL Item
A little of the time  (4)
CL Item
None of the time (5)
Item
e) Did you have a lot of energy?
integer
C3484316 (UMLS CUI [1])
CL Item
All of the time  (1)
CL Item
Most of the time  (2)
CL Item
Some of the time  (3)
CL Item
A little of the time  (4)
CL Item
None of the time (5)
Item
f) Have you felt downhearted and blue?
integer
C3475472 (UMLS CUI [1])
Code List
f) Have you felt downhearted and blue?
CL Item
All of the time  (1)
CL Item
Most of the time  (2)
CL Item
Some of the time  (3)
CL Item
A little of the time  (4)
CL Item
None of the time (5)
Item
g) Did you feel worn out?
integer
C3484315 (UMLS CUI [1])
CL Item
All of the time  (1)
CL Item
Most of the time  (2)
CL Item
Some of the time  (3)
CL Item
A little of the time  (4)
CL Item
None of the time (5)
Item
h) Have you been a happy person?
integer
C3475468 (UMLS CUI [1])
CL Item
All of the time  (1)
CL Item
Most of the time  (2)
CL Item
Some of the time  (3)
CL Item
A little of the time  (4)
CL Item
None of the time (5)
Item
i) Did you feel tired?
integer
C3484314 (UMLS CUI [1])
CL Item
All of the time  (1)
CL Item
Most of the time  (2)
CL Item
Some of the time  (3)
CL Item
A little of the time  (4)
CL Item
None of the time (5)
Item
10. 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.)?
integer
C3484327 (UMLS CUI [1])
Code List
10. 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.)?
CL Item
All of the time  (1)
CL Item
Most of the time  (2)
CL Item
Some of the time  (3)
CL Item
A little of the time  (4)
CL Item
None of the time (5)
How TRUE or FALSE is each of the following statements for you.
Item
11. How TRUE or FALSE is each of the following statements for you.
text
Item
a) I seem to get sick a little easier than other people
integer
C3899028 (UMLS CUI [1])
Code List
a) I seem to get sick a little easier than other people
CL Item
Definitely true (1)
CL Item
Mostly true (2)
CL Item
Don't know (3)
CL Item
Mostly false (4)
CL Item
Definitely false (5)
Item
b) I am as healthy as anybody I know
integer
C3900054 (UMLS CUI [1])
Code List
b) I am as healthy as anybody I know
CL Item
Definitely true (1)
CL Item
Mostly true (2)
CL Item
Don't know (3)
CL Item
Mostly false (4)
CL Item
Definitely false (5)
Item
c) I expect my health to get worse
integer
C3475697 (UMLS CUI [1])
Code List
c) I expect my health to get worse
CL Item
Definitely true (1)
CL Item
Mostly true (2)
CL Item
Don't know (3)
CL Item
Mostly false (4)
CL Item
Definitely false (5)
Item
d) My health is excellent
integer
C3476206 (UMLS CUI [1])
Code List
d) My health is excellent
CL Item
Definitely true (1)
CL Item
Mostly true (2)
CL Item
Don't know (3)
CL Item
Mostly false (4)
CL Item
Definitely false (5)

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