ID

18221

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 (1)
  1. 10/25/16 10/25/16 -
Uploaded on

October 25, 2016

DOI

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License

Creative Commons BY 4.0
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Maintenance Period - Visit 13 Maintenance Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

German English

Maintenance Period - Visit 13 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
Vitalzeichen
Description

Vitalzeichen

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
Studienmedikation
Description

Studienmedikation

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
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Similar models

Maintenance Period - Visit 13 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
Vitalzeichen
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
Studienmedikation
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)
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