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Spirometry

1 forms  
  1. StudyEvent: ODM
    1. Spirometry
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. The Visit on Day 28 is denoted as "Follow-Up" for Part A but not for Part B.

Data type

integer

Alias
UMLS CUI [1]
C3641100
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Dosing Date and Time
Description

Dosing Date and Time

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

only applicable to Day 1 Visits

Data type

datetime

Alias
UMLS CUI [1,1]
C3897500
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
Spirometry
Description

Spirometry

Alias
UMLS CUI-1
C0037981
Time relative to dosing
Description

Applicable to Day 1 only. All cohorts have to perform the predose measurement, subjects of cohort 7 additionally the 7 hours post start of infusion measurement and all other cohorts the 6 hours post start of infusion measurement.

Data type

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
Measurement Number
Description

for Repeat / Unscheduled assessments

Data type

integer

Alias
UMLS CUI [1,1]
C0037981
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0242485
Date/time of test (Start of Assessment)
Description

Spirometry Date/Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0037981
UMLS CUI [1,2]
C1264639
FEV1 (Best of 3)
Description

FEV1

Data type

float

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
FVC (Best of 3)
Description

FVC

Data type

float

Measurement units
  • L
Alias
UMLS CUI [1]
C1287681
L
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Similar models

Spirometry

1 forms
  1. StudyEvent: ODM
    1. Spirometry
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])
Type of Visit
Code List
Type of Visit
CL Item
Screening (1)
CL Item
Early Withdrawal (2)
CL Item
Part A/B, Day 1 (3)
CL Item
Part A/B, Day 2 (4)
CL Item
Part A/B, Day 28 (5)
CL Item
Repeat Assessment (6)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Dosing Date and Time
C0178602 (UMLS CUI-1)
C1264639 (UMLS CUI-2)
Start Dosing date/time
Item
Start Dosing date/time
datetime
C3897500 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item Group
Spirometry
C0037981 (UMLS CUI-1)
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Time relative to dosing
Code List
Time relative to dosing
CL Item
Predose (1)
CL Item
6 Hours Post Start of Infusion (2)
CL Item
7 Hours Post Start of Infusion (3)
Repeat Spirometry Measurement Number
Item
Measurement Number
integer
C0037981 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
Spirometry Date/Time
Item
Date/time of test (Start of Assessment)
datetime
C0037981 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
FEV1
Item
FEV1 (Best of 3)
float
C0748133 (UMLS CUI [1])
FVC
Item
FVC (Best of 3)
float
C1287681 (UMLS CUI [1])
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