ID

18229

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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Early Termination Visit - Visit 17 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

German English

Early Termination Visit - Visit 17 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

1 forms  
Date of Visit
Description

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of Visit
Description

Date of Visit

Data type

text

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C1320303
YYYY-MM-DD
Was the study terminated prematurely?
Description

early termination

Data type

integer

Alias
UMLS CUI [1]
C2718058
LDH
Description

LDH

Alias
UMLS CUI-1
C0202113
LDH
Description

Sub-Itemgroup: Demographics

Data type

float

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

Weight

Alias
UMLS CUI-1
C0005910
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Vital signs
Description

Vital signs

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

Sub-Itemgroup: Vital Signs

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
1. Diastolic blood pressure
Description

Sub-Itemgroup: Vital Signs

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
2. Systolic blood pressure
Description

Sub-Itemgroup: Vital Signs

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
2. Diastolic blood pressure
Description

Sub-Itemgroup: Vital Signs

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
3. Systolic blood pressure
Description

Sub-Itemgroup: Vital Signs

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
3. Diastolic blood pressure
Description

Sub-Itemgroup: Vital Signs

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Sitting heart rate
Description

Sub-Itemgroup: Vital Signs

Data type

integer

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

Sub-Itemgroup: Vital Signs

Data type

float

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

Examinations

Alias
UMLS CUI-1
C0582103
Physical examination
Description

Physical examination

Data type

integer

Alias
UMLS CUI [1]
C0031809
Abdominal ultrasound
Description

Abdominal ultrasound

Data type

integer

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

12-lead electrocardiogram

Data type

integer

Alias
UMLS CUI [1]
C0430456
Six-Minute Walk Test
Description

Six-Minute Walk Test

Alias
UMLS CUI-1
C0430515
Walk distance
Description

Sub-Itemgroup: Six-Minute Walk Test

Data type

integer

Measurement units
  • Meter
Alias
UMLS CUI [1]
C3854161
Meter
Does the patient report symptoms of dyspnea?
Description

Sub-Itemgroup: Six-Minute Walk Test

Data type

integer

Alias
UMLS CUI [1]
C0013404
Circulatory Symptoms
Description

Circulatory Symptoms

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

Thrombophlebitis/Deep Vein Thrombosis

Data type

integer

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

Pulmonary Embolus

Data type

integer

Alias
UMLS CUI [1]
C0034065
Cerebrovascular Accident
Description

Cerebrovascular Accident

Data type

integer

Alias
UMLS CUI [1]
C0038454
Amputation
Description

Amputation

Data type

integer

Alias
UMLS CUI [1]
C0002688
Myocardial Infarction
Description

Myocardial Infarction

Data type

integer

Alias
UMLS CUI [1]
C0027051
Transient Ischemic Attack
Description

Transient Ischemic Attack

Data type

integer

Alias
UMLS CUI [1]
C0007787
Unstable Angina
Description

Unstable Angina

Data type

integer

Alias
UMLS CUI [1]
C0002965
Renal Vein Thrombosis
Description

Renal Vein Thrombosis

Data type

integer

Alias
UMLS CUI [1]
C0238457
Mesenteric Vein Thrombosis
Description

Mesenteric Vein Thrombosis

Data type

integer

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

Portal Vein Thrombosis (Budd-Chiari)

Data type

integer

Alias
UMLS CUI [1]
C0155773
Gangrene
Description

Gangrene

Data type

integer

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

Acute Peripheral Vascular Occlusion

Data type

integer

Alias
UMLS CUI [1]
C0240728
Sudden Death
Description

Sudden Death

Data type

integer

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

Patient suffers from other accompanying illnesses?

Data type

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?

Data type

integer

Alias
UMLS CUI [1]
C0032976
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Study medication
Description

Study medication

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

Patient received the study medication

Data type

integer

Alias
UMLS CUI [1]
C2826299
Comments
Description

study medication comments

Data type

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

Data type

text

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C0807937
YYYY-MM-DD
Signature investigator
Description

Signature investigator

Data type

integer

Alias
UMLS CUI [1]
C2346576
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Similar models

Early Termination Visit - Visit 17 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
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
Weight
C0005910 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (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
Examinations
C0582103 (UMLS CUI-1)
Item
Physical examination
integer
C0031809 (UMLS CUI [1])
Physical examination
Code List
Physical examination
CL Item
without pathologic findings  (0)
CL Item
with pathologic findings (1)
Item
Abdominal ultrasound
integer
C2348813 (UMLS CUI [1])
Abdominal ultrasound
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])
12-lead electrocardiogram
Code List
12-lead electrocardiogram
CL Item
without pathologic findings  (0)
CL Item
with pathologic findings (1)
Item Group
Six-Minute Walk Test
C0430515 (UMLS CUI-1)
Walk distance
Item
Walk distance
integer
C3854161 (UMLS CUI [1])
Item
Does the patient report symptoms of dyspnea?
integer
C0013404 (UMLS CUI [1])
dyspnea
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)
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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