ID

18168

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

Lien

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

Mots-clés

Versions (2)
  1. 24/10/2016 24/10/2016 -
  2. 24/10/2016 24/10/2016 -
Téléchargé le

24 octobre 2016

DOI

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Licence

Creative Commons BY 4.0
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Induction Period - Visit 2 Baseline UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

Allemand Anglais

Induction Period - Visit 2 Baseline UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

1 Formulaires  
Date of Visit
Description

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of Visit
Description

Date of Visit

Type de données

text

Unités de mesure
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C1320303
YYYY-MM-DD
Patient is eligible for study (All inclusion criteria apply and no exclusion criteria)
Description

eligibility

Type de données

integer

Alias
UMLS CUI [1]
C1302261
Was the study terminated prematurely?
Description

early termination

Type de données

integer

Alias
UMLS CUI [1]
C2718058
LDH
Description

LDH

Alias
UMLS CUI-1
C0202113
LDH
Description

Sub-Itemgroup: Demographics

Type de données

float

Unités de mesure
  • U/l
Alias
UMLS CUI [1]
C0202113
U/l
Patient Identification card
Description

Patient Identification card

Alias
UMLS CUI-1
C0030692
Patient Identification card
Description

Patient Identification card

Type de données

integer

Alias
UMLS CUI [1]
C0030692
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
1. Systolic blood pressure
Description

Sub-Itemgroup: Vital Signs

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
1. Diastolic blood pressure
Description

Sub-Itemgroup: Vital Signs

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
2. Systolic blood pressure
Description

Sub-Itemgroup: Vital Signs

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
2. Diastolic blood pressure
Description

Sub-Itemgroup: Vital Signs

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
3. Systolic blood pressure
Description

Sub-Itemgroup: Vital Signs

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
3. Diastolic blood pressure
Description

Sub-Itemgroup: Vital Signs

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Sitting heart rate
Description

Sub-Itemgroup: Vital Signs

Type de données

integer

Unités de mesure
  • beats per minute
Alias
UMLS CUI [1]
C2029904
beats per minute
Body temperature
Description

Sub-Itemgroup: Vital Signs

Type de données

float

Unités de mesure
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Circulatory Symptoms
Description

Circulatory Symptoms

Alias
UMLS CUI-1
C0476270
Thrombophlebitis/Deep Vein Thrombosis
Description

Thrombophlebitis/Deep Vein Thrombosis

Type de données

integer

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

Pulmonary Embolus

Type de données

integer

Alias
UMLS CUI [1]
C0034065
Cerebrovascular Accident
Description

Cerebrovascular Accident

Type de données

integer

Alias
UMLS CUI [1]
C0038454
Amputation
Description

Amputation

Type de données

integer

Alias
UMLS CUI [1]
C0002688
Myocardial Infarction
Description

Myocardial Infarction

Type de données

integer

Alias
UMLS CUI [1]
C0027051
Transient Ischemic Attack
Description

Transient Ischemic Attack

Type de données

integer

Alias
UMLS CUI [1]
C0007787
Unstable Angina
Description

Unstable Angina

Type de données

integer

Alias
UMLS CUI [1]
C0002965
Renal Vein Thrombosis
Description

Renal Vein Thrombosis

Type de données

integer

Alias
UMLS CUI [1]
C0238457
Mesenteric Vein Thrombosis
Description

Mesenteric Vein Thrombosis

Type de données

integer

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

Portal Vein Thrombosis (Budd-Chiari)

Type de données

integer

Alias
UMLS CUI [1]
C0155773
Gangrene
Description

Gangrene

Type de données

integer

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

Acute Peripheral Vascular Occlusion

Type de données

integer

Alias
UMLS CUI [1]
C0240728
Sudden Death
Description

Sudden Death

Type de données

integer

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

Patient suffers from other accompanying illnesses?

Type de données

integer

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

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

Type de données

integer

Alias
UMLS CUI [1]
C0032976
Comments
Description

Comments

Type de données

text

Alias
UMLS CUI [1]
C0947611
Study medication
Description

Study medication

Alias
UMLS CUI-1
C0013227
Patient received the study medication (600mg)
Description

Patient received the study medication

Type de données

integer

Alias
UMLS CUI [1]
C2826299
Comments
Description

study medication comments

Type de données

text

Alias
UMLS CUI [1]
C2826299
Signature principal investigator
Description

Signature principal investigator

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

Signature date

Type de données

text

Unités de mesure
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C0807937
YYYY-MM-DD
Signature investigator
Description

Signature investigator

Type de données

integer

Alias
UMLS CUI [1]
C2346576
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Similar models

Induction Period - Visit 2 Baseline UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
text
C1320303 (UMLS CUI [1])
Item
Patient is eligible for study (All inclusion criteria apply and no exclusion criteria)
integer
C1302261 (UMLS CUI [1])
eligibility
Code List
Patient is eligible for study (All inclusion criteria apply and no exclusion criteria)
CL Item
no (0)
CL Item
yes (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
Patient Identification card
C0030692 (UMLS CUI-1)
Item
Patient Identification card
integer
C0030692 (UMLS CUI [1])
Patient Identification card
Code List
Patient Identification card
CL Item
no (0)
CL Item
yes (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 (600mg)
integer
C2826299 (UMLS CUI [1])
Patient received the study medication
Code List
Patient received the study medication (600mg)
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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