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

In-/Exclusion Criteria
Beschreibung

In-/Exclusion Criteria

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

Patient number

Datentyp

integer

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

The patient gave his or her consent on

Datentyp

text

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

Are all inclusion criteria fulfilled?

Datentyp

integer

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

Are none of the exclusion criteria fulfilled?

Datentyp

integer

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

Demographics, Vital Signs and Examinations

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

Itemgroup: Date of Screening

Datentyp

text

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

Sub-Itemgroup: Demographics

Datentyp

text

Maßeinheiten
  • YYYY-MM
Alias
UMLS CUI [1]
C0421451
YYYY-MM
Sex
Beschreibung

Sex

Datentyp

integer

Alias
UMLS CUI [1]
C0079399
Nationality
Beschreibung

Sub-Itemgroup: Demographics

Datentyp

integer

Alias
UMLS CUI [1]
C0027473
specify nationality
Beschreibung

Sub-Itemgroup: Demographics

Datentyp

text

Alias
UMLS CUI [1]
C0027473
Height
Beschreibung

Sub-Itemgroup: Demographics

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Sub-Itemgroup: Demographics

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
LDH
Beschreibung

Sub-Itemgroup: Demographics

Datentyp

float

Maßeinheiten
  • U/l
Alias
UMLS CUI [1]
C0202113
U/l
1. Systolic blood pressure
Beschreibung

Sub-Itemgroup: Vital Signs

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
1. Diastolic blood pressure
Beschreibung

Sub-Itemgroup: Vital Signs

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
2. Systolic blood pressure
Beschreibung

Sub-Itemgroup: Vital Signs

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
2. Diastolic blood pressure
Beschreibung

Sub-Itemgroup: Vital Signs

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
3. Systolic blood pressure
Beschreibung

Sub-Itemgroup: Vital Signs

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
3. Diastolic blood pressure
Beschreibung

Sub-Itemgroup: Vital Signs

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Sitting heart rate
Beschreibung

Sub-Itemgroup: Vital Signs

Datentyp

integer

Maßeinheiten
  • beats per minute
Alias
UMLS CUI [1]
C2029904
beats per minute
Body temperature
Beschreibung

Sub-Itemgroup: Vital Signs

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Physical examination
Beschreibung

Sub-Itemgroup: Examinations

Datentyp

integer

Alias
UMLS CUI [1]
C0031809
Abdominal ultrasound
Beschreibung

Sub-Itemgroup: Examinations

Datentyp

integer

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

Sub-Itemgroup: Examinations

Datentyp

integer

Alias
UMLS CUI [1]
C0430456
Bone marrow
Beschreibung

Sub-Itemgroup: Examinations

Datentyp

integer

Alias
UMLS CUI [1]
C0005957
Walk distance
Beschreibung

Sub-Itemgroup: Six-Minute Walk Test

Datentyp

integer

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

Sub-Itemgroup: Six-Minute Walk Test

Datentyp

integer

Alias
UMLS CUI [1]
C0013404
Circulatory Symptoms
Beschreibung

Circulatory Symptoms

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

Date of first Cold Agglutin Disease

Datentyp

date

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

Thrombophlebitis/Deep Vein Thrombosis

Datentyp

integer

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

Pulmonary Embolus

Datentyp

integer

Alias
UMLS CUI [1]
C0034065
Cerebrovascular Accident
Beschreibung

Cerebrovascular Accident

Datentyp

integer

Alias
UMLS CUI [1]
C0038454
Amputation
Beschreibung

Amputation

Datentyp

integer

Alias
UMLS CUI [1]
C0002688
Myocardial Infarction
Beschreibung

Myocardial Infarction

Datentyp

integer

Alias
UMLS CUI [1]
C0027051
Transient Ischemic Attack
Beschreibung

Transient Ischemic Attack

Datentyp

integer

Alias
UMLS CUI [1]
C0007787
Unstable Angina
Beschreibung

Unstable Angina

Datentyp

integer

Alias
UMLS CUI [1]
C0002965
Renal Vein Thrombosis
Beschreibung

Renal Vein Thrombosis

Datentyp

integer

Alias
UMLS CUI [1]
C0238457
Mesenteric Vein Thrombosis
Beschreibung

Mesenteric Vein Thrombosis

Datentyp

integer

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

Portal Vein Thrombosis (Budd-Chiari)

Datentyp

integer

Alias
UMLS CUI [1]
C0155773
Gangrene
Beschreibung

Gangrene

Datentyp

integer

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

Acute Peripheral Vascular Occlusion

Datentyp

integer

Alias
UMLS CUI [1]
C0240728
Sudden Death
Beschreibung

Sudden Death

Datentyp

integer

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

Patient suffers from other accompanying illnesses?

Datentyp

integer

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

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

Datentyp

integer

Alias
UMLS CUI [1]
C0032976
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Signature date
Beschreibung

Sub-Itemgroup: Investigator's signature

Datentyp

date

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

Sub-Itemgroup: Investigator's signature

Datentyp

integer

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

One year transfusion history

Alias
UMLS CUI-1
C1519604
Date of blood transfusion
Beschreibung

Date of blood transfusion

Datentyp

date

Maßeinheiten
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C1264703
YYYY-MM-DD
Number of units
Beschreibung

Number of units

Datentyp

integer

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

Hemoglobin before transfusion

Datentyp

float

Maßeinheiten
  • ulHGB
Alias
UMLS CUI [1]
C0518015
ulHGB
Any special events circumstances transfusion?
Beschreibung

Any special events circumstances transfusion?

Datentyp

integer

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

if yes, please specify

Datentyp

text

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

Sub-Itemgroup: Investigator's signature

Datentyp

date

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

Sub-Itemgroup: Investigator's signature

Datentyp

integer

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

Preexisting and concomitant diseases

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

Concomitant disease

Datentyp

integer

Alias
UMLS CUI [1]
C0243087
Signature date
Beschreibung

Sub-Itemgroup: Investigator's signature

Datentyp

date

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

Sub-Itemgroup: Investigator's signature

Datentyp

integer

Alias
UMLS CUI [1]
C2346576
Preexisting and concomitant
Beschreibung

Preexisting and concomitant

Alias
UMLS CUI-1
C0243087
CD No
Beschreibung

CD No

Datentyp

text

Visit 0 - FACIT
Beschreibung

Visit 0 - FACIT

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

lack of vitality

Datentyp

integer

Alias
UMLS CUI [1]
C1337102
nausea
Beschreibung

nausea

Datentyp

integer

Alias
UMLS CUI [1]
C0027497
General health deterioration
Beschreibung

General health deterioration

Datentyp

integer

Alias
UMLS CUI [1]
C0563273
pain
Beschreibung

pain

Datentyp

integer

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

treatment side-effects

Datentyp

integer

Alias
UMLS CUI [1]
C0879626
feeling of illness
Beschreibung

feeling of illness

Datentyp

integer

Alias
UMLS CUI [1]
C0231218
Visit 0 - SF36
Beschreibung

Visit 0 - SF36

Alias
UMLS CUI-1
C1512346
UMLS CUI-2
C3640521

Ähnliche Modelle

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

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
Item
nausea
integer
C0027497 (UMLS CUI [1])
Code List
nausea
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
Item
General health deterioration
integer
C0563273 (UMLS CUI [1])
Code List
General health deterioration
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
Item
pain
integer
C0030193 (UMLS CUI [1])
Code List
pain
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
Item
treatment side-effects
integer
C0879626 (UMLS CUI [1])
Code List
treatment side-effects
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
Item
feeling of illness
integer
C0231218 (UMLS CUI [1])
Code List
feeling of illness
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
Item Group
Visit 0 - SF36
C1512346 (UMLS CUI-1)
C3640521 (UMLS CUI-2)