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Holter

1 Formulär  
  1. StudyEvent: ODM
    1. Holter
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Type of Visit
Beskrivning

Identical for all Parts/Cohorts/Subcohorts.

Datatyp

integer

Alias
UMLS CUI [1]
C3641100
Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Holter
Beskrivning

Holter

Alias
UMLS CUI-1
C0013801
Measurement number
Beskrivning

only for repeat/unscheduled assessment

Datatyp

integer

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

[hidden] optional

Datatyp

datetime

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

Start Date/Time of Holter

Datatyp

datetime

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

Stop Date/Time of Holter

Datatyp

datetime

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

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

Datatyp

integer

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

Holter

1 Formulär
  1. StudyEvent: ODM
    1. Holter
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Type of Visit
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])
Interpretation of Holter
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)
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