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12-Lead-ECG

1 forms  
  1. StudyEvent: ODM
    1. 12-Lead-ECG
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of Visit/Assessment
Description

Date of Visit/Assessment

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Site
Description

Study site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Description

Subject No.

Data type

text

Alias
UMLS CUI [1]
C2348585
Study Visit
Description

Visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Dosing Date and Time
Description

Dosing Date and Time

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
UMLS CUI-3
C1264639
Dosing date/time
Description

This item applies to Visits 6 and 7 only

Data type

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1264639
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Measurement Type
Description

At Visit 1 / Screening, select "Measurement 1". At Visit 6 and EW, select "Timepoint 1". At Visit 7, select "10h". For all other visits, skip this item.

Data type

text

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0332307
Date and Time of ECG
Description

ECG Date/Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1264639
Result of the ECG
Description

If Abnormal - Clinically significant: complete the AE form if the abnormality meets the protocol definition for an AE

Data type

text

Alias
UMLS CUI [1]
C0438154
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Similar models

12-Lead-ECG

1 forms
  1. StudyEvent: ODM
    1. 12-Lead-ECG
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Study site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Subject No.
Item
Patient No.
text
C2348585 (UMLS CUI [1])
Item
Study Visit
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Study Visit
Code List
Study Visit
CL Item
Visit 1 (Visit 1)
CL Item
Visit 6 (Visit 6)
CL Item
Visit 7 (Visit 7)
CL Item
EW (EW)
CL Item
Day 7 Follow Up (Day 7 Follow Up)
CL Item
Day 14 Follow Up (Day 14 Follow Up)
CL Item
Logs/Repeats (Logs/Repeats)
Item Group
Dosing Date and Time
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
Dosing date/time
Item
Dosing date/time
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Item
Measurement Type
text
C0242485 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Measurement Type
Code List
Measurement Type
CL Item
Measurement 1 (Measurement 1)
CL Item
Timepoint 1 (Timepoint 1)
CL Item
10h (10h)
ECG Date/Time
Item
Date and Time of ECG
datetime
C0430456 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Result of the ECG
text
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (Normal)
CL Item
Abnormal - Not clinically significant (Abnormal - Not clinically significant)
CL Item
No result (not available) (No result (not available))
CL Item
Abnormal - Clinically significant (Abnormal - Clinically significant)
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