Engelsk

Visit 7

1 Formulär  
  1. StudyEvent: ODM
    1. Visit 7
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject identifier
Beskrivning

Subject identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Investigational Product Container Number
Beskrivning

Investigational Product Container Number

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0180098
UMLS CUI-3
C0600091
Investigational Product Container Number
Beskrivning

Investigational Product Container Number

Datatyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Vital Signs
Beskrivning

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic Blood pressure
Beskrivning

Blood pressure measures must be taken with the subject in the seated position, having been seated at least 5 minutes before the measurements are taken.

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood pressure
Beskrivning

Blood pressure measures must be taken with the subject in the seated position, having been seated at least 5 minutes before the measurements are taken.

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate measures must be taken with the subject in the seated position, having been seated at least 5 minutes before the measurements are taken.

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Nasal Examination
Beskrivning

Nasal Examination

Alias
UMLS CUI-1
C0558826
Left Nostril patent?
Beskrivning

Patency of Left Nostril

Datatyp

text

Alias
UMLS CUI [1,1]
C0429212
UMLS CUI [1,2]
C0205091
Right Nostril patent?
Beskrivning

Patency of Right Nostril

Datatyp

text

Alias
UMLS CUI [1,1]
C0429212
UMLS CUI [1,2]
C0205090
Septum normal?
Beskrivning

Septum

Datatyp

text

Alias
UMLS CUI [1]
C0027432
If septum not normal, is it deviated to the left or right?
Beskrivning

Septum Deviation

Datatyp

integer

Alias
UMLS CUI [1]
C0549397
Mucosal oedema left nostril
Beskrivning

Mucosal oedema left nostril

Datatyp

integer

Alias
UMLS CUI [1,1]
C0521481
UMLS CUI [1,2]
C0028429
UMLS CUI [1,3]
C0205091
Mucosal oedema right nostril
Beskrivning

Mucosal oedema right nostril

Datatyp

integer

Alias
UMLS CUI [1,1]
C0521481
UMLS CUI [1,2]
C0028429
UMLS CUI [1,3]
C0205090
Crusting of left nasal Mucosa
Beskrivning

Crusting of left nasal Mucosa

Datatyp

integer

Alias
UMLS CUI [1,1]
C0205204
UMLS CUI [1,2]
C0027428
UMLS CUI [1,3]
C0205091
Crusting of right nasal Mucosa
Beskrivning

Crusting of right nasal Mucosa

Datatyp

integer

Alias
UMLS CUI [1,1]
C0205204
UMLS CUI [1,2]
C0027428
UMLS CUI [1,3]
C0205090
Bleeding of Left Nasal Mucosa
Beskrivning

Bleeding of Left Nasal Mucosa

Datatyp

integer

Alias
UMLS CUI [1,1]
C0014591
UMLS CUI [1,2]
C0205091
Bleeding of Right Nasal Mucosa
Beskrivning

Bleeding of right Nasal Mucosa

Datatyp

integer

Alias
UMLS CUI [1,1]
C0014591
UMLS CUI [1,2]
C0205090
Secretion from left nostril
Beskrivning

Secretion from left nostril

Datatyp

integer

Alias
UMLS CUI [1,1]
C1546724
UMLS CUI [1,2]
C0205091
Predominant Color of Secretion from left nostril
Beskrivning

Color of Secretion from left nostril

Datatyp

integer

Alias
UMLS CUI [1,1]
C1880121
UMLS CUI [1,2]
C1546724
UMLS CUI [1,3]
C0205091
Secretion from right nostril
Beskrivning

Secretion from right Nostril

Datatyp

integer

Alias
UMLS CUI [1,1]
C1546724
UMLS CUI [1,2]
C0205090
Predominant Color of Secretion from right nostril
Beskrivning

Color of Secretion from right Nostril

Datatyp

integer

Alias
UMLS CUI [1,1]
C1880121
UMLS CUI [1,2]
C1546724
UMLS CUI [1,3]
C0205090
Ulcers on left turbinates
Beskrivning

Ulcers on left turbinates

Datatyp

integer

Alias
UMLS CUI [1,1]
C1407910
UMLS CUI [1,2]
C0205091
Ulcers on left nasal septum
Beskrivning

Ulcers on left nasal septum

Datatyp

integer

Alias
UMLS CUI [1,1]
C0264268
UMLS CUI [1,2]
C0205091
Ulcers on right turbinates
Beskrivning

Ulcers on right turbinates

Datatyp

integer

Alias
UMLS CUI [1,1]
C1407910
UMLS CUI [1,2]
C0205090
Ulcers on right nasal septum
Beskrivning

Ulcers on right nasal septum

Datatyp

integer

Alias
UMLS CUI [1,1]
C0264268
UMLS CUI [1,2]
C0205090
Polyposis of left turbinates
Beskrivning

Size of the largest polyp, if present

Datatyp

integer

Alias
UMLS CUI [1,1]
C0027430
UMLS CUI [1,2]
C2087484
UMLS CUI [1,3]
C0205091
Polyposis of left nasal septum
Beskrivning

Size of the largest polyp, if present

Datatyp

integer

Alias
UMLS CUI [1,1]
C0027430
UMLS CUI [1,2]
C0027432
UMLS CUI [1,3]
C0205091
Polyposis of right turbinates
Beskrivning

Size of the largest polyp, if present

Datatyp

integer

Alias
UMLS CUI [1,1]
C0027430
UMLS CUI [1,2]
C2087484
UMLS CUI [1,3]
C0205090
Polyposis of right nasal septum
Beskrivning

Size of the largest polyp, if present

Datatyp

integer

Alias
UMLS CUI [1,1]
C0027430
UMLS CUI [1,2]
C0027432
UMLS CUI [1,3]
C0205090
Nasal Candidiasis Examination
Beskrivning

Nasal Candidiasis Examination

Alias
UMLS CUI-1
C2239140
UMLS CUI-2
C0006840
Does the subject have clinical evidence of nasal candidias?
Beskrivning

Subjects with evidence of Candidiasis are not eligible for the study. f there is clinical evidence of nasal candidiasis: Ensure that a swab has been taken. Ensure that all medications used to treat the infection are recorded on the Concomitant Medications page. Ensure that nasal candidiasis when present is recorded on the Current Medical Conditions page.

Datatyp

text

Alias
UMLS CUI [1]
C0919658
Was a swab taken?
Beskrivning

Nasal Swab taken

Datatyp

text

Alias
UMLS CUI [1]
C3669207
Nasal Swab result
Beskrivning

Ensure that only one result of the swab has been recorded and is correct. If swab result will never be known ensure that ’Not Available’ is marked.

Datatyp

integer

Alias
UMLS CUI [1,1]
C3669207
UMLS CUI [1,2]
C1274040
Tillbaka till toppen

Similar models

Visit 7

1 Formulär
  1. StudyEvent: ODM
    1. Visit 7
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Investigational Product Container Number
C0304229 (UMLS CUI-1)
C0180098 (UMLS CUI-2)
C0600091 (UMLS CUI-3)
Investigational Product Container Number
Item
Investigational Product Container Number
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Diastolic Blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Nasal Examination
C0558826 (UMLS CUI-1)
Item
Left Nostril patent?
text
C0429212 (UMLS CUI [1,1])
C0205091 (UMLS CUI [1,2])
Patency of Left Nostril
Code List
Left Nostril patent?
CL Item
Yes (Y)
CL Item
No (N)
Item
Right Nostril patent?
text
C0429212 (UMLS CUI [1,1])
C0205090 (UMLS CUI [1,2])
Patency of Left Nostril
Code List
Right Nostril patent?
CL Item
Yes (Y)
CL Item
No (N)
Item
Septum normal?
text
C0027432 (UMLS CUI [1])
Patency of Left Nostril
Code List
Septum normal?
CL Item
Yes (Y)
CL Item
No (N)
Item
If septum not normal, is it deviated to the left or right?
integer
C0549397 (UMLS CUI [1])
Septum Deviation
Code List
If septum not normal, is it deviated to the left or right?
CL Item
left (1)
CL Item
right (2)
Item
Mucosal oedema left nostril
integer
C0521481 (UMLS CUI [1,1])
C0028429 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
Mucosal oedema left nostril
Code List
Mucosal oedema left nostril
CL Item
absent (0)
CL Item
present (1)
Item
Mucosal oedema right nostril
integer
C0521481 (UMLS CUI [1,1])
C0028429 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
Mucosal oedema left nostril
Code List
Mucosal oedema right nostril
CL Item
absent (0)
CL Item
present (1)
Item
Crusting of left nasal Mucosa
integer
C0205204 (UMLS CUI [1,1])
C0027428 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
Mucosal oedema left nostril
Code List
Crusting of left nasal Mucosa
CL Item
absent (0)
CL Item
present (1)
Item
Crusting of right nasal Mucosa
integer
C0205204 (UMLS CUI [1,1])
C0027428 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
Mucosal oedema left nostril
Code List
Crusting of right nasal Mucosa
CL Item
absent (0)
CL Item
present (1)
Item
Bleeding of Left Nasal Mucosa
integer
C0014591 (UMLS CUI [1,1])
C0205091 (UMLS CUI [1,2])
Mucosal oedema left nostril
Code List
Bleeding of Left Nasal Mucosa
CL Item
absent (0)
CL Item
present (1)
Item
Bleeding of Right Nasal Mucosa
integer
C0014591 (UMLS CUI [1,1])
C0205090 (UMLS CUI [1,2])
Mucosal oedema left nostril
Code List
Bleeding of Right Nasal Mucosa
CL Item
absent (0)
CL Item
present (1)
Item
Secretion from left nostril
integer
C1546724 (UMLS CUI [1,1])
C0205091 (UMLS CUI [1,2])
Mucosal oedema left nostril
Code List
Secretion from left nostril
CL Item
absent (0)
CL Item
present (1)
Item
Predominant Color of Secretion from left nostril
integer
C1880121 (UMLS CUI [1,1])
C1546724 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
Mucosal oedema left nostril
Code List
Predominant Color of Secretion from left nostril
CL Item
Clear (1)
CL Item
Yellow (2)
CL Item
Green (3)
Item
Secretion from right nostril
integer
C1546724 (UMLS CUI [1,1])
C0205090 (UMLS CUI [1,2])
Mucosal oedema left nostril
Code List
Secretion from right nostril
CL Item
absent (0)
CL Item
present (1)
Item
Predominant Color of Secretion from right nostril
integer
C1880121 (UMLS CUI [1,1])
C1546724 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
Mucosal oedema left nostril
Code List
Predominant Color of Secretion from right nostril
CL Item
Clear (1)
CL Item
Yellow (2)
CL Item
Green (3)
Item
Ulcers on left turbinates
integer
C1407910 (UMLS CUI [1,1])
C0205091 (UMLS CUI [1,2])
Ulcers on left turbinates
Code List
Ulcers on left turbinates
CL Item
None (1)
CL Item
Small (less than 2 mm) (2)
CL Item
Large (2 mm or more) (3)
Item
Ulcers on left nasal septum
integer
C0264268 (UMLS CUI [1,1])
C0205091 (UMLS CUI [1,2])
Ulcers on left turbinates
Code List
Ulcers on left nasal septum
CL Item
None (1)
CL Item
Small (less than 2 mm) (2)
CL Item
Large (2 mm or more) (3)
Item
Ulcers on right turbinates
integer
C1407910 (UMLS CUI [1,1])
C0205090 (UMLS CUI [1,2])
Ulcers on left turbinates
Code List
Ulcers on right turbinates
CL Item
None (1)
CL Item
Small (less than 2 mm) (2)
CL Item
Large (2 mm or more) (3)
Item
Ulcers on right nasal septum
integer
C0264268 (UMLS CUI [1,1])
C0205090 (UMLS CUI [1,2])
Ulcers on left turbinates
Code List
Ulcers on right nasal septum
CL Item
None (1)
CL Item
Small (less than 2 mm) (2)
CL Item
Large (2 mm or more) (3)
Item
Polyposis of left turbinates
integer
C0027430 (UMLS CUI [1,1])
C2087484 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
Ulcers on left turbinates
Code List
Polyposis of left turbinates
CL Item
None (1)
CL Item
Small (less than 2 mm) (2)
CL Item
Large (2 mm or more) (3)
Item
Polyposis of left nasal septum
integer
C0027430 (UMLS CUI [1,1])
C0027432 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
Ulcers on left turbinates
Code List
Polyposis of left nasal septum
CL Item
None (1)
CL Item
Small (less than 2 mm) (2)
CL Item
Large (2 mm or more) (3)
Item
Polyposis of right turbinates
integer
C0027430 (UMLS CUI [1,1])
C2087484 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
Ulcers on left turbinates
Code List
Polyposis of right turbinates
CL Item
None (1)
CL Item
Small (less than 2 mm) (2)
CL Item
Large (2 mm or more) (3)
Item
Polyposis of right nasal septum
integer
C0027430 (UMLS CUI [1,1])
C0027432 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
Ulcers on left turbinates
Code List
Polyposis of right nasal septum
CL Item
None (1)
CL Item
Small (less than 2 mm) (2)
CL Item
Large (2 mm or more) (3)
Item Group
Nasal Candidiasis Examination
C2239140 (UMLS CUI-1)
C0006840 (UMLS CUI-2)
Item
Does the subject have clinical evidence of nasal candidias?
text
C0919658 (UMLS CUI [1])
Patency of Left Nostril
Code List
Does the subject have clinical evidence of nasal candidias?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was a swab taken?
text
C3669207 (UMLS CUI [1])
Patency of Left Nostril
Code List
Was a swab taken?
CL Item
Yes (Y)
CL Item
No (N)
Item
Nasal Swab result
integer
C3669207 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Nasal Swab result
Code List
Nasal Swab result
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not Available (4)
Tillbaka till toppen