ID

18077

Descripción

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

Palabras clave

  1. 7/10/16 7/10/16 -
  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. 2/11/16 2/11/16 -
Subido en

18 de octubre de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

In-/Exclusion Criteria
Descripción

In-/Exclusion Criteria

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

Patient number

Tipo de datos

integer

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

The patient gave his or her consent on

Tipo de datos

text

Unidades de medida
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C2985782
YYYY-MM-DD
Are all inclusion criteria fulfilled?
Descripción

Are all inclusion criteria fulfilled?

Tipo de datos

integer

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

Are none of the exclusion criteria fulfilled?

Tipo de datos

integer

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

Demographics, Vital Signs and Examinations

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

Itemgroup: Date of Screening

Tipo de datos

text

Unidades de medida
  • YYYY-MM-DD
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1710477
YYYY-MM-DD
Date of Birth
Descripción

Sub-Itemgroup: Demographics

Tipo de datos

text

Unidades de medida
  • YYYY-MM
Alias
UMLS CUI [1]
C0421451
YYYY-MM
Sex
Descripción

Sex

Tipo de datos

integer

Alias
UMLS CUI [1]
C0079399
Nationality
Descripción

Sub-Itemgroup: Demographics

Tipo de datos

integer

Alias
UMLS CUI [1]
C0027473
specify nationality
Descripción

Sub-Itemgroup: Demographics

Tipo de datos

text

Alias
UMLS CUI [1]
C0027473
Height
Descripción

Sub-Itemgroup: Demographics

Tipo de datos

float

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Descripción

Sub-Itemgroup: Demographics

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
LDH
Descripción

Sub-Itemgroup: Demographics

Tipo de datos

float

Unidades de medida
  • U/l
Alias
UMLS CUI [1]
C0202113
U/l
1. Systolic blood pressure
Descripción

Sub-Itemgroup: Vital Signs

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
1. Diastolic blood pressure
Descripción

Sub-Itemgroup: Vital Signs

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
2. Systolic blood pressure
Descripción

Sub-Itemgroup: Vital Signs

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
2. Diastolic blood pressure
Descripción

Sub-Itemgroup: Vital Signs

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
3. Systolic blood pressure
Descripción

Sub-Itemgroup: Vital Signs

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
3. Diastolic blood pressure
Descripción

Sub-Itemgroup: Vital Signs

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Sitting heart rate
Descripción

Sub-Itemgroup: Vital Signs

Tipo de datos

integer

Unidades de medida
  • beats per minute
Alias
UMLS CUI [1]
C2029904
beats per minute
Body temperature
Descripción

Sub-Itemgroup: Vital Signs

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Physical examination
Descripción

Sub-Itemgroup: Examinations

Tipo de datos

integer

Alias
UMLS CUI [1]
C0031809
Abdominal ultrasound
Descripción

Sub-Itemgroup: Examinations

Tipo de datos

integer

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

Sub-Itemgroup: Examinations

Tipo de datos

integer

Alias
UMLS CUI [1]
C0430456
Bone marrow
Descripción

Sub-Itemgroup: Examinations

Tipo de datos

integer

Alias
UMLS CUI [1]
C0005957
Walk distance
Descripción

Sub-Itemgroup: Six-Minute Walk Test

Tipo de datos

integer

Unidades de medida
  • Meter
Alias
UMLS CUI [1]
C3854161
Meter
Does the patient report symptoms of dyspnea?
Descripción

Sub-Itemgroup: Six-Minute Walk Test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013404
Circulatory Symptoms
Descripción

Circulatory Symptoms

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

Date of first Cold Agglutin Disease

Tipo de datos

date

Unidades de medida
  • YYYY-MM-DD
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0175816
YYYY-MM-DD
Thrombophlebitis/Deep Vein Thrombosis
Descripción

Thrombophlebitis/Deep Vein Thrombosis

Tipo de datos

integer

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

Pulmonary Embolus

Tipo de datos

integer

Alias
UMLS CUI [1]
C0034065
Cerebrovascular Accident
Descripción

Cerebrovascular Accident

Tipo de datos

integer

Alias
UMLS CUI [1]
C0038454
Amputation
Descripción

Amputation

Tipo de datos

integer

Alias
UMLS CUI [1]
C0002688
Myocardial Infarction
Descripción

Myocardial Infarction

Tipo de datos

integer

Alias
UMLS CUI [1]
C0027051
Transient Ischemic Attack
Descripción

Transient Ischemic Attack

Tipo de datos

integer

Alias
UMLS CUI [1]
C0007787
Unstable Angina
Descripción

Unstable Angina

Tipo de datos

integer

Alias
UMLS CUI [1]
C0002965
Renal Vein Thrombosis
Descripción

Renal Vein Thrombosis

Tipo de datos

integer

Alias
UMLS CUI [1]
C0238457
Mesenteric Vein Thrombosis
Descripción

Mesenteric Vein Thrombosis

Tipo de datos

integer

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

Portal Vein Thrombosis (Budd-Chiari)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0155773
Gangrene
Descripción

Gangrene

Tipo de datos

integer

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

Acute Peripheral Vascular Occlusion

Tipo de datos

integer

Alias
UMLS CUI [1]
C0240728
Sudden Death
Descripción

Sudden Death

Tipo de datos

integer

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

Patient suffers from other accompanying illnesses?

Tipo de datos

integer

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

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

Tipo de datos

integer

Alias
UMLS CUI [1]
C0032976
Comments
Descripción

Comments

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Signature date
Descripción

Sub-Itemgroup: Investigator's signature

Tipo de datos

date

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

Sub-Itemgroup: Investigator's signature

Tipo de datos

integer

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

One year transfusion history

Alias
UMLS CUI-1
C1519604
Date of blood transfusion
Descripción

Date of blood transfusion

Tipo de datos

date

Unidades de medida
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C1264703
YYYY-MM-DD
Number of units
Descripción

Number of units

Tipo de datos

integer

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

Hemoglobin before transfusion

Tipo de datos

float

Unidades de medida
  • ulHGB
Alias
UMLS CUI [1]
C0518015
ulHGB
Any special events circumstances transfusion?
Descripción

Any special events circumstances transfusion?

Tipo de datos

integer

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

if yes, please specify

Tipo de datos

text

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

Sub-Itemgroup: Investigator's signature

Tipo de datos

date

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

Sub-Itemgroup: Investigator's signature

Tipo de datos

integer

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

Preexisting and concomitant diseases

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

Concomitant disease

Tipo de datos

integer

Alias
UMLS CUI [1]
C0243087
Signature date
Descripción

Sub-Itemgroup: Investigator's signature

Tipo de datos

date

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

Sub-Itemgroup: Investigator's signature

Tipo de datos

integer

Alias
UMLS CUI [1]
C2346576
Preexisting and concomitant
Descripción

Preexisting and concomitant

Alias
UMLS CUI-1
C0243087
CD No
Descripción

CD No

Tipo de datos

text

Visit 0 - FACIT
Descripción

Visit 0 - FACIT

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

lack of vitality

Tipo de datos

integer

Alias
UMLS CUI [1]
C1337102
nausea
Descripción

nausea

Tipo de datos

integer

Alias
UMLS CUI [1]
C0027497
General health deterioration
Descripción

General health deterioration

Tipo de datos

integer

Alias
UMLS CUI [1]
C0563273
pain
Descripción

pain

Tipo de datos

integer

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

treatment side-effects

Tipo de datos

integer

Alias
UMLS CUI [1]
C0879626
feeling of illness
Descripción

feeling of illness

Tipo de datos

integer

Alias
UMLS CUI [1]
C0231218
bedrest
Descripción

bedrest

Tipo de datos

integer

Alias
UMLS CUI [1]
C0004910
Freunden nahe
Descripción

interacts with close friends

Tipo de datos

integer

Alias
UMLS CUI [1]
C0518615
Family support
Descripción

family support

Tipo de datos

integer

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

receives support from friends

Tipo de datos

integer

Alias
UMLS CUI [1]
C2984072
accepts disease
Descripción

accepts disease

Tipo de datos

integer

satisfied with talking about
Descripción

satisfied with talking about

Tipo de datos

text

satisfied with talking about disease
Descripción

satisfied with talking about disease

Tipo de datos

integer

feel close to other people
Descripción

feel close to other people

Tipo de datos

integer

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

satisfied with sex life

Tipo de datos

integer

Alias
UMLS CUI [1]
C2984060
sadness
Descripción

sadness

Tipo de datos

integer

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

satisfied with fighting against the illness

Tipo de datos

integer

losing hope
Descripción

losing hope

Tipo de datos

integer

Alias
UMLS CUI [1]
C2984056
nervousness
Descripción

nervousness

Tipo de datos

integer

Alias
UMLS CUI [1]
C0027769
worries about death
Descripción

worries about death

Tipo de datos

integer

Alias
UMLS CUI [1]
C2984076
worries about condition
Descripción

worries about condition

Tipo de datos

integer

Alias
UMLS CUI [1]
C2984075
able to work
Descripción

able to work

Tipo de datos

integer

Alias
UMLS CUI [1]
C2984044
satisfied with work
Descripción

satisfied with work

Tipo de datos

integer

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

able to enjoy life

Tipo de datos

integer

Alias
UMLS CUI [1]
C2984051
cope with disease
Descripción

cope with disease

Tipo de datos

integer

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

sleeping

Tipo de datos

integer

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

able to enjoy leisure

Tipo de datos

integer

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

currently satisfied with life

Tipo de datos

integer

Alias
UMLS CUI [1]
C1954023
fatigue
Descripción

fatigue

Tipo de datos

integer

Alias
UMLS CUI [1]
C0015672
weak
Descripción

weak

Tipo de datos

integer

Alias
UMLS CUI [1]
C3714552
listless
Descripción

listless

Tipo de datos

integer

Alias
UMLS CUI [1]
C0023380
tired
Descripción

tired

Tipo de datos

integer

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

tiredness limiting starting things

Tipo de datos

integer

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

tiredness limits finishing things

Tipo de datos

integer

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

having energy

Tipo de datos

integer

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

able to do usual activities

Tipo de datos

integer

Alias
UMLS CUI [1]
C0441655
sleep during daytime
Descripción

sleep during daytime

Tipo de datos

integer

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

too tired to eat

Tipo de datos

integer

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

need help with usual activities

Tipo de datos

integer

Alias
UMLS CUI [1]
C3898152
frustrated by fatigue
Descripción

frustrated by fatigue

Tipo de datos

integer

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

fatigue limiting social activity

Tipo de datos

integer

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

Visit 0 - SF36

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

general health condition

Tipo de datos

integer

Alias
UMLS CUI [1]
C1142435
2. Compared to one year ago, how would you rate your health in general now?
Descripción

current state of health

Tipo de datos

integer

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?
Descripción

limited in activities

Tipo de datos

text

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

Vigorous activities

Tipo de datos

integer

Alias
UMLS CUI [1]
C3827557
b) Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf
Descripción

Moderate activities

Tipo de datos

integer

Alias
UMLS CUI [1]
C3833417
c) Lifting or carrying groceries
Descripción

Lifting or carrying groceries

Tipo de datos

integer

Alias
UMLS CUI [1]
C3829286
d) Climbing several flights of stairs
Descripción

Climbing several flights of stairs

Tipo de datos

integer

Alias
UMLS CUI [1]
C3831080
e) Climbing one flight of stairs
Descripción

Climbing one flight of stairs

Tipo de datos

integer

f) Bending, kneeling, or stooping
Descripción

Bending, kneeling, or stooping

Tipo de datos

integer

Alias
UMLS CUI [1]
C3831371
g) Walking more than a mile
Descripción

Walking more than a mile

Tipo de datos

integer

Alias
UMLS CUI [1]
C3827523
h) Walking several blocks
Descripción

Walking several blocks

Tipo de datos

integer

Alias
UMLS CUI [1]
C3827521
i) Walking one block
Descripción

Walking one block

Tipo de datos

integer

Alias
UMLS CUI [1]
C3827522
j) Bathing or dressing yourself
Descripción

Bathing or dressing yourself

Tipo de datos

integer

Alias
UMLS CUI [1]
C3831396
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?
Descripción

problems in past 4 weeks

Tipo de datos

text

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

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

Tipo de datos

integer

Alias
UMLS CUI [1]
C0585074
b) Accomplished less than you would like
Descripción

Accomplished less than you would like

Tipo de datos

integer

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

Were limited in the kind of work or other activities

Tipo de datos

integer

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

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

Tipo de datos

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)?
Descripción

emotional problems

Tipo de datos

text

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

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

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0585074
UMLS CUI [1,2]
C0677660
b) Accomplished less than you would like
Descripción

Accomplished less than you would like

Tipo de datos

integer

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

Didnt do work or other activities as carefully as usual

Tipo de datos

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?
Descripción

emotional problems limiting social activities

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0677660
UMLS CUI [1,2]
C3829529
7. How much bodily pain have you had during the past 4 weeks?
Descripción

bodily pain during the past 4 weeks

Tipo de datos

integer

Alias
UMLS CUI [1]
C0030193
8. During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?
Descripción

pain interfere with your normal work

Tipo de datos

integer

Alias
UMLS CUI [1]
C3898033
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.
Descripción

feelings last 4 weeks

Tipo de datos

text

a) Did you feel full of pep?
Descripción

Did you feel full of pep?

Tipo de datos

integer

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

Have you been a very nervous person?

Tipo de datos

integer

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

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

Tipo de datos

integer

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

Have you felt calm and peaceful?

Tipo de datos

integer

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

Did you have a lot of energy?

Tipo de datos

integer

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

Have you felt downhearted and blue?

Tipo de datos

integer

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

Did you feel worn out?

Tipo de datos

integer

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

Have you been a happy person?

Tipo de datos

integer

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

Did you feel tired?

Tipo de datos

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.)?
Descripción

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.)?

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0677660
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C3641834
11. How TRUE or FALSE is each of the following statements for you.
Descripción

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

Tipo de datos

text

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

I seem to get sick a little easier than other people

Tipo de datos

integer

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

I am as healthy as anybody I know

Tipo de datos

integer

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

I expect my health to get worse

Tipo de datos

integer

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

My health is excellent

Tipo de datos

integer

Alias
UMLS CUI [1]
C3476206

Similar models

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

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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-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])
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)
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
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
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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (5)
satisfied with talking about
Item
text
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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
Quite a bit (4)
CL Item
Extremely (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
C1142435 (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
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
C3827557 (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
C3833417 (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
C3829286 (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
C3831080 (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
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
C3831371 (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
C3827523 (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
C3827521 (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
C3827522 (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
C3831396 (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
C0585074 (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
C0585074 (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
C0677660 (UMLS CUI [1,1])
C3829529 (UMLS CUI [1,2])
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
C0030193 (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
C3898033 (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
Quite a bit (4)
CL Item
Extremely (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
C0677660 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C3641834 (UMLS CUI [1,3])
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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