1. StudyEvent: ODM
    1. Holter
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Type of Visit
Description

Identical for all Parts/Cohorts/Subcohorts.

Data type

integer

Alias
UMLS CUI [1]
C3641100
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Holter
Description

Holter

Alias
UMLS CUI-1
C0013801
Measurement number
Description

only for repeat/unscheduled assessment

Data type

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0242485
Dosing date/time
Description

[hidden] optional

Data type

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
Start Date and Time of Holter
Description

Start Date/Time of Holter

Data type

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C3897500
Stop Date and Time of Holter
Description

Stop Date/Time of Holter

Data type

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C3899266
Interpretation of Holter
Description

If Abnormal - Clinically significant: complete the abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE

Data type

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0438154

Similar models

Holter

  1. StudyEvent: ODM
    1. Holter
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item
Type of Visit
integer
C3641100 (UMLS CUI [1])
Code List
Type of Visit
CL Item
Screening (1)
CL Item
Part A/B Day 1 (1 hour predose to 24 hours post start of infusion) (2)
CL Item
Repeat Assessment (3)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Holter
C0013801 (UMLS CUI-1)
Holter measurement number
Item
Measurement number
integer
C0013801 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
Dosing date/time
Item
Dosing date/time
datetime
C1264639 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Start Date/Time of Holter
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C3897500 (UMLS CUI [1,2])
Stop Date/Time of Holter
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C3899266 (UMLS CUI [1,2])
Item
Interpretation of Holter
integer
C0013801 (UMLS CUI [1,1])
C0438154 (UMLS CUI [1,2])
Code List
Interpretation of Holter
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (optional item) (4)
CL Item
Unable to evaluate (optional item) (5)