ID

18181

Description

Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose

Link

https://clinicaltrials.gov/ct2/show/NCT01303952

Keywords

Versions (2)
  1. 24.10.16 24.10.16 -
  2. 24.10.16 24.10.16 -
Uploaded on

24. Oktober 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Maintenance Period - Visit 7 Maintenance Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

German English

Maintenance Period - Visit 7 Maintenance Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

1 forms  
Datum der Visite
Description

Datum der Visite

Alias
UMLS CUI-1
C1320303
Datum der Visite
Description

Date of Visit

Data type

text

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C1320303
YYYY-MM-DD
Wurde die Studie vorzeitig beendet?
Description

early termination

Data type

integer

Alias
UMLS CUI [1]
C2718058
LDH
Description

LDH

Alias
UMLS CUI-1
C0202113
LDH
Description

LDH

Data type

float

Measurement units
  • U/l
Alias
UMLS CUI [1]
C0202113
U/l
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
1. Systolischer Blutdruck
Description

1. Systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
1. Diastolischer Blutdruck
Description

1. Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
2. Systolischer Blutdruck
Description

2. Systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
2. Diastolischer Blutdruck
Description

2. Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
3. Systolischer Blutdruck
Description

3. Systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
3. Diastolischer Blutdruck
Description

3. Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Herzfrequenz, sitzend
Description

Sitting heart rate

Data type

integer

Measurement units
  • beats per minute
Alias
UMLS CUI [1]
C2029904
beats per minute
Körpertemperatur
Description

Body temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Kardiovaskuläre Symptome
Description

Kardiovaskuläre Symptome

Alias
UMLS CUI-1
C0476270
Thrombophlebitis/Tiefe Beinvenenthrombose
Description

Thrombophlebitis/Deep Vein Thrombosis

Data type

integer

Alias
UMLS CUI [1]
C0040046
UMLS CUI [2]
C0149871
Lungenembolie
Description

Pulmonary Embolus

Data type

integer

Alias
UMLS CUI [1]
C0034065
Zerebrovaskuläres Ereignis
Description

Cerebrovascular Accident

Data type

integer

Alias
UMLS CUI [1]
C0038454
Amputation
Description

Amputation

Data type

integer

Alias
UMLS CUI [1]
C0002688
Myokardinfarkt
Description

Myocardial Infarction

Data type

integer

Alias
UMLS CUI [1]
C0027051
Transitorische ischämische Attacke
Description

Transient Ischemic Attack

Data type

integer

Alias
UMLS CUI [1]
C0007787
Instabile Angina
Description

Unstable Angina

Data type

integer

Alias
UMLS CUI [1]
C0002965
Nierenvenenthrombose
Description

Renal Vein Thrombosis

Data type

integer

Alias
UMLS CUI [1]
C0238457
Mesenterialvenenthrombose
Description

Mesenteric Vein Thrombosis

Data type

integer

Alias
UMLS CUI [1]
C0267412
Pfortaderthrombose (Budd-Chiari)
Description

Portal Vein Thrombosis (Budd-Chiari)

Data type

integer

Alias
UMLS CUI [1]
C0155773
Gangrän
Description

Gangrene

Data type

integer

Alias
UMLS CUI [1]
C0017086
Akute periphere Verschlusskrankheit
Description

Acute Peripheral Vascular Occlusion

Data type

integer

Alias
UMLS CUI [1]
C0240728
Plötzlicher Tod
Description

Sudden Death

Data type

integer

Alias
UMLS CUI [1]
C0011071
Leidet der Patient an Begleiterkrankungen?
Description

Patient suffers from other accompanying illnesses?

Data type

integer

Alias
UMLS CUI [1]
C0009488
Für Frauen (unter 50): Ist der Schwangerschaftstest negativ?
Description

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

Data type

integer

Alias
UMLS CUI [1]
C0032976
Kommentar
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Study medication
Description

Study medication

Alias
UMLS CUI-1
C0013227
Patient hat Studienmedikation erhalten (900mg)
Description

Patient received the study medication

Data type

integer

Alias
UMLS CUI [1]
C2826299
Kommentar
Description

study medication comments

Data type

text

Alias
UMLS CUI [1]
C2826299
Unterschrift Prüfarzt
Description

Unterschrift Prüfarzt

Alias
UMLS CUI-1
C1519316
UMLS CUI-2
C1521895
Datum
Description

Signature date

Data type

text

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C0807937
YYYY-MM-DD
Unterschrift Prüfarzt
Description

Signature investigator

Data type

integer

Alias
UMLS CUI [1]
C2346576
Back to the top of the page

Similar models

Maintenance Period - Visit 7 Maintenance Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Datum der Visite
C1320303 (UMLS CUI-1)
Date of Visit
Item
Datum der Visite
text
C1320303 (UMLS CUI [1])
Item
Wurde die Studie vorzeitig beendet?
integer
C2718058 (UMLS CUI [1])
dyspnea
Code List
Wurde die Studie vorzeitig beendet?
CL Item
Nein (0)
CL Item
Ja (1)
Item Group
LDH
C0202113 (UMLS CUI-1)
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
Item Group
C0518766 (UMLS CUI-1)
1. Systolic blood pressure
Item
1. Systolischer Blutdruck
integer
C0871470 (UMLS CUI [1])
1. Diastolic blood pressure
Item
1. Diastolischer Blutdruck
integer
C0428883 (UMLS CUI [1])
2. Systolic blood pressure
Item
2. Systolischer Blutdruck
integer
C0871470 (UMLS CUI [1])
2. Diastolic blood pressure
Item
2. Diastolischer Blutdruck
integer
C0428883 (UMLS CUI [1])
3. Systolic blood pressure
Item
3. Systolischer Blutdruck
integer
C0871470 (UMLS CUI [1])
3. Diastolic blood pressure
Item
3. Diastolischer Blutdruck
integer
C0428883 (UMLS CUI [1])
Sitting heart rate
Item
Herzfrequenz, sitzend
integer
C2029904 (UMLS CUI [1])
Body temperature
Item
Körpertemperatur
float
C0005903 (UMLS CUI [1])
Item Group
Kardiovaskuläre Symptome
C0476270 (UMLS CUI-1)
Item
Thrombophlebitis/Tiefe Beinvenenthrombose
integer
C0040046 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Thrombophlebitis/Tiefe Beinvenenthrombose
CL Item
Nein (0)
CL Item
Ja (1)
Item
Lungenembolie
integer
C0034065 (UMLS CUI [1])
Pulmonary Embolus
Code List
Lungenembolie
CL Item
Nein (0)
CL Item
Ja (1)
Item
Zerebrovaskuläres Ereignis
integer
C0038454 (UMLS CUI [1])
Cerebrovascular Accident
Code List
Zerebrovaskuläres Ereignis
CL Item
Nein (0)
CL Item
Ja (1)
Item
Amputation
integer
C0002688 (UMLS CUI [1])
Amputation
Code List
Amputation
CL Item
Nein (0)
CL Item
Ja (1)
Item
Myokardinfarkt
integer
C0027051 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Myokardinfarkt
CL Item
 (0)
CL Item
 (1)
Item
Transitorische ischämische Attacke
integer
C0007787 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Transitorische ischämische Attacke
CL Item
Nein (0)
CL Item
Ja (1)
Item
Instabile Angina
integer
C0002965 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Instabile Angina
CL Item
Nein (0)
CL Item
Ja (1)
Item
Nierenvenenthrombose
integer
C0238457 (UMLS CUI [1])
Pulmonary Embolus
Code List
Nierenvenenthrombose
CL Item
 (0)
CL Item
 (1)
Item
Mesenterialvenenthrombose
integer
C0267412 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Mesenterialvenenthrombose
CL Item
Nein (0)
CL Item
Ja (1)
Item
Pfortaderthrombose (Budd-Chiari)
integer
C0155773 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Pfortaderthrombose (Budd-Chiari)
CL Item
Nein (0)
CL Item
Ja (1)
Item
Gangrän
integer
C0017086 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Gangrän
CL Item
Nein (0)
CL Item
Ja (1)
Item
Akute periphere Verschlusskrankheit
integer
C0240728 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Akute periphere Verschlusskrankheit
CL Item
Nein (0)
CL Item
Ja (1)
Item
Plötzlicher Tod
integer
C0011071 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Plötzlicher Tod
CL Item
Nein (0)
CL Item
Ja (1)
Item
Leidet der Patient an Begleiterkrankungen?
integer
C0009488 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Leidet der Patient an Begleiterkrankungen?
CL Item
Nein (0)
CL Item
Ja (1)
Item
Für Frauen (unter 50): Ist der Schwangerschaftstest negativ?
integer
C0032976 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Für Frauen (unter 50): Ist der Schwangerschaftstest negativ?
CL Item
Nein (0)
CL Item
Ja (1)
Comments
Item
Kommentar
text
C0947611 (UMLS CUI [1])
Item Group
C0013227 (UMLS CUI-1)
Item
Patient hat Studienmedikation erhalten (900mg)
integer
C2826299 (UMLS CUI [1])
Patient received the study medication
Code List
Patient hat Studienmedikation erhalten (900mg)
CL Item
Nein (0)
CL Item
Ja (1)
study medication comments
Item
Kommentar
text
C2826299 (UMLS CUI [1])
Item Group
Unterschrift Prüfarzt
C1519316 (UMLS CUI-1)
C1521895 (UMLS CUI-2)
Signature date
Item
Datum
text
C0807937 (UMLS CUI [1])
Item
Unterschrift Prüfarzt
integer
C2346576 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Unterschrift Prüfarzt
CL Item
Nein (0)
CL Item
Ja (1)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial