ID

18216

Beschreibung

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

Stichworte

Versionen (1)
  1. 25.10.16 25.10.16 -
Hochgeladen am

25. Oktober 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Maintenance Period - Visit 11 Maintenance Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

Deutsch Englisch

Maintenance Period - Visit 11 Maintenance Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

1 Formulare  
Date of Visit
Beschreibung

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of Visit
Beschreibung

Date of Visit

Datentyp

text

Maßeinheiten
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C1320303
YYYY-MM-DD
Was the study terminated prematurely?
Beschreibung

early termination

Datentyp

integer

Alias
UMLS CUI [1]
C2718058
LDH
Beschreibung

LDH

Alias
UMLS CUI-1
C0202113
LDH
Beschreibung

Sub-Itemgroup: Demographics

Datentyp

float

Maßeinheiten
  • U/l
Alias
UMLS CUI [1]
C0202113
U/l
Vital signs
Beschreibung

Vital signs

Alias
UMLS CUI-1
C0518766
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
Circulatory Symptoms
Beschreibung

Circulatory Symptoms

Alias
UMLS CUI-1
C0476270
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
Study medication
Beschreibung

Study medication

Alias
UMLS CUI-1
C0013227
Patient received the study medication (900mg)
Beschreibung

Patient received the study medication

Datentyp

integer

Alias
UMLS CUI [1]
C2826299
Comments
Beschreibung

study medication comments

Datentyp

text

Alias
UMLS CUI [1]
C2826299
Signature principal investigator
Beschreibung

Signature principal investigator

Alias
UMLS CUI-1
C1519316
UMLS CUI-2
C1521895
Signature date
Beschreibung

Signature date

Datentyp

text

Maßeinheiten
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C0807937
YYYY-MM-DD
Signature investigator
Beschreibung

Signature investigator

Datentyp

integer

Alias
UMLS CUI [1]
C2346576
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Ähnliche Modelle

Maintenance Period - Visit 11 Maintenance Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
text
C1320303 (UMLS CUI [1])
Item
Was the study terminated prematurely?
integer
C2718058 (UMLS CUI [1])
dyspnea
Code List
Was the study terminated prematurely?
CL Item
no (0)
CL Item
yes (1)
Item Group
LDH
C0202113 (UMLS CUI-1)
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
Item Group
Vital signs
C0518766 (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 Group
Circulatory Symptoms
C0476270 (UMLS CUI-1)
Item
Thrombophlebitis/Deep Vein Thrombosis
integer
C0040046 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Thrombophlebitis/Deep Vein Thrombosis
CL Item
no (0)
CL Item
yes (1)
Item
Pulmonary Embolus
integer
C0034065 (UMLS CUI [1])
Pulmonary Embolus
Code List
Pulmonary Embolus
CL Item
no (0)
CL Item
yes (1)
Item
Cerebrovascular Accident
integer
C0038454 (UMLS CUI [1])
Cerebrovascular Accident
Code List
Cerebrovascular Accident
CL Item
no (0)
CL Item
yes (1)
Item
Amputation
integer
C0002688 (UMLS CUI [1])
Amputation
Code List
Amputation
CL Item
no (0)
CL Item
yes (1)
Item
Myocardial Infarction
integer
C0027051 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Myocardial Infarction
CL Item
no (0)
CL Item
yes (1)
Item
Transient Ischemic Attack
integer
C0007787 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Transient Ischemic Attack
CL Item
no (0)
CL Item
yes (1)
Item
Unstable Angina
integer
C0002965 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Unstable Angina
CL Item
no (0)
CL Item
yes (1)
Item
Renal Vein Thrombosis
integer
C0238457 (UMLS CUI [1])
Pulmonary Embolus
Code List
Renal Vein Thrombosis
CL Item
no (0)
CL Item
yes (1)
Item
Mesenteric Vein Thrombosis
integer
C0267412 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Mesenteric Vein Thrombosis
CL Item
no (0)
CL Item
yes (1)
Item
Portal Vein Thrombosis (Budd-Chiari)
integer
C0155773 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Portal Vein Thrombosis (Budd-Chiari)
CL Item
no (0)
CL Item
yes (1)
Item
Gangrene
integer
C0017086 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Gangrene
CL Item
no (0)
CL Item
yes (1)
Item
Acute Peripheral Vascular Occlusion
integer
C0240728 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Acute Peripheral Vascular Occlusion
CL Item
no (0)
CL Item
yes (1)
Item
Sudden Death
integer
C0011071 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Sudden Death
CL Item
no (0)
CL Item
yes (1)
Item
Patient suffers from other accompanying illnesses?
integer
C0009488 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
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])
Thrombophlebitis/Deep Vein Thrombosis
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])
Item Group
Study medication
C0013227 (UMLS CUI-1)
Item
Patient received the study medication (900mg)
integer
C2826299 (UMLS CUI [1])
Patient received the study medication
Code List
Patient received the study medication (900mg)
CL Item
no (0)
CL Item
yes (1)
study medication comments
Item
Comments
text
C2826299 (UMLS CUI [1])
Item Group
Signature principal investigator
C1519316 (UMLS CUI-1)
C1521895 (UMLS CUI-2)
Signature date
Item
Signature date
text
C0807937 (UMLS CUI [1])
Item
Signature investigator
integer
C2346576 (UMLS CUI [1])
Thrombophlebitis/Deep Vein Thrombosis
Code List
Signature investigator
CL Item
no (0)
CL Item
yes (1)
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