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Biomarker Serum/WBA

1 Formulär  
  1. StudyEvent: ODM
    1. Biomarker Serum/WBA
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date/Time of Assessment
Beskrivning

Date/Time of Assessment

Datatyp

datetime

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C1264639
Cohort
Beskrivning

Cohort

Datatyp

text

Alias
UMLS CUI [1]
C0599755
Dosing date/time
Beskrivning

Dosing date/time

Alias
UMLS CUI-1
C0178602
UMLS CUI-2
C1264639
Dosing date/time
Beskrivning

Optional and read-only, applicable only to Day 1 samples

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1264639
Biomarkers
Beskrivning

Biomarkers

Alias
UMLS CUI-1
C0005516
UMLS CUI-2
C0370003
Scheduled Date/Time Biomarker sample
Beskrivning

Fill in the entire itemgroup for each applicable time point below Day 1, 6 Hours Post Start of Infusion: in Study Part A only for Serum, in Study Part B for Serum and WBA Day 3: in Study Part A only for Serum, in Study Part B for Serum and WBA Day 28: Serum only in both Study Parts

Datatyp

integer

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0005516
UMLS CUI [1,3]
C0200345
UMLS CUI [1,4]
C1301732
Biomarker Specimen Type
Beskrivning

Note that collection of specimens on Day -1, 1, 3 and 28 varies by type.

Datatyp

integer

Alias
UMLS CUI [1,1]
C2347029
UMLS CUI [1,2]
C0005516
Biomarkers Collection Date
Beskrivning

not applicable to collection on Day 1

Datatyp

date

Alias
UMLS CUI [1,1]
C0005516
UMLS CUI [1,2]
C1302413
Biomarkers Collection Time
Beskrivning

optional

Datatyp

time

Alias
UMLS CUI [1,1]
C0005516
UMLS CUI [1,2]
C4064021
Sample Number
Beskrivning

Applicable only to repeat samples, and to Day -1 Predose for BWA in Study Part A, as two samples need to be taken for BWA in Study Part A on this Day.

Datatyp

integer

Alias
UMLS CUI [1]
C1299222
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Similar models

Biomarker Serum/WBA

1 Formulär
  1. StudyEvent: ODM
    1. Biomarker Serum/WBA
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])
Date/Time of Assessment
Item
Date/Time of Assessment
datetime
C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Cohort
text
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
Part A Cohort 1 (A)
CL Item
Part A Cohort 2 (B)
CL Item
Part A Cohort 3 (C)
CL Item
Part B Cohort 4 (D)
CL Item
Part B Cohort 5 (E)
CL Item
Part B Cohort 6 (F)
CL Item
Part B Cohort 7 (open label) (G)
Item Group
Dosing date/time
C0178602 (UMLS CUI-1)
C1264639 (UMLS CUI-2)
Dosing date/time
Item
Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item Group
Biomarkers
C0005516 (UMLS CUI-1)
C0370003 (UMLS CUI-2)
Item
Scheduled Date/Time Biomarker sample
integer
C1264639 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Scheduled Date/Time Biomarker sample
Code List
Scheduled Date/Time Biomarker sample
CL Item
Day -1 Predose (1)
CL Item
Day 1 2 Hours Post Start of Infusion (2)
CL Item
Day 1 6 Hours Post Start of Infusion (3)
CL Item
Day 2  (4)
CL Item
Day 3 (5)
CL Item
Day 28 (6)
CL Item
Unscheduled (7)
Item
Biomarker Specimen Type
integer
C2347029 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
Biomarker Specimen Type
Code List
Biomarker Specimen Type
CL Item
Serum (1)
CL Item
WBA (2)
Biomarkers Collection Date
Item
Biomarkers Collection Date
date
C0005516 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Biomarkers Collection Time
Item
Biomarkers Collection Time
time
C0005516 (UMLS CUI [1,1])
C4064021 (UMLS CUI [1,2])
Sample Number
Item
Sample Number
integer
C1299222 (UMLS CUI [1])
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