ID

30211

Beskrivning

Study ID: 102123 Clinical Study ID: FFR102123 Study Title: A randomised double-blind placebo controlled parallel group multicentre long term study to evaluate the safety of once-daily, intranasal administration of GW685698X aqueous nasal spray 100mcg* for 52 weeks in adult and adolescent subjects with perennial allergic rhinitis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: FLUTIDE, Allermist, Veramyst, FLUNASE, FLIXOTAIDE, FLUTAIDE, FLIXOVATE, Avamys; Veramyst, Avamys, Allermist Study Indication: Rhinitis, Allergic, Perennial This ODM-file contains Nasal and Ophthalmic Examination, Vital Signs, ECG; Visit 15, Week 52, Day 365+/-2 days.

Nyckelord

Versioner (1)
  1. 2018-05-18 2018-05-18 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

18 maj 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Safety of once-daily administration of Fluticasone nasal spray in adults and adolescents with perennial allergic rhinitis GSK 102123

Engelsk

Nasal and Opthalmic Examination, Vital Signs, ECG - Visit 15

1 Formulär  
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

If 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 Non-Serious Adverse Events or Serious Adverse Events page(s) if applicable.

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; results of previous swabs have to be recorded at the appropriate visit. 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
Ophthalmic Examination
Beskrivning

Ophthalmic Examination

Alias
UMLS CUI-1
C0200149
Date of Ophthalmic Examination
Beskrivning

Answer once

Datatyp

date

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0011008
Time of Opthalmic Examination
Beskrivning

Answer once

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200149
Name of Ophthalmologist/Optometrist performing the examination
Beskrivning

Answer once

Datatyp

text

Alias
UMLS CUI [1,1]
C1704292
UMLS CUI [1,2]
C2826892
UMLS CUI [2,1]
C1704292
UMLS CUI [2,2]
C0029146
Examined Side
Beskrivning

Answer each of the following items of this itemgroup for both sides

Datatyp

text

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0200149
Intraocular Pressure
Beskrivning

Tonometry (Goldmann Applanation)

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0578862
mmHg
Macula
Beskrivning

Macula

Datatyp

integer

Alias
UMLS CUI [1]
C0423419
Cup Disc
Beskrivning

Cup Disc

Datatyp

integer

Måttenheter
  • %
Alias
UMLS CUI [1]
C0278233
%
Pigment/Naevus
Beskrivning

Pigment/Naevus

Datatyp

integer

Alias
UMLS CUI [1]
C0423417
Retinal Vessels
Beskrivning

Retinal Vessels

Datatyp

integer

Alias
UMLS CUI [1]
C0035330
Exudates
Beskrivning

Exudates

Datatyp

integer

Alias
UMLS CUI [1]
C0240897
Microaneurysms
Beskrivning

Microaneurysms

Datatyp

integer

Alias
UMLS CUI [1]
C0154834
Retinal haemorrhage
Beskrivning

Retinal haemorrhage

Datatyp

integer

Alias
UMLS CUI [1]
C0035317
Cornea
Beskrivning

Cornea

Datatyp

integer

Alias
UMLS CUI [1]
C0010031
If abnormal cornea, indicate if epithelial location.
Beskrivning

Epithelial Abnormality of Cornea

Datatyp

text

Alias
UMLS CUI [1,1]
C1855670
UMLS CUI [1,2]
C0459875
If abnormal cornea, indicate if stromal location.
Beskrivning

Stromal Abnormality of Cornea

Datatyp

text

Alias
UMLS CUI [1,1]
C1855670
UMLS CUI [1,2]
C0010040
If abnormal cornea, indicate if endothelial location.
Beskrivning

Endothelial Abnormality of Cornea

Datatyp

text

Alias
UMLS CUI [1,1]
C1855670
UMLS CUI [1,2]
C0014259
Iris
Beskrivning

Iris

Datatyp

integer

Alias
UMLS CUI [1]
C0022077
Pupil
Beskrivning

Pupil

Datatyp

integer

Alias
UMLS CUI [1]
C0034121
Cataract
Beskrivning

Cataract

Datatyp

text

Alias
UMLS CUI [1]
C0086543
If there is a cataract present, indicate the type
Beskrivning

Cataract type

Datatyp

integer

Alias
UMLS CUI [1,1]
C0086543
UMLS CUI [1,2]
C0332307
If posterior subcapsular cataract, how extensive?
Beskrivning

Extent of posterior subcapsular cataract

Datatyp

integer

Alias
UMLS CUI [1,1]
C0858617
UMLS CUI [1,2]
C0439792
Conjunctival Cyst
Beskrivning

Conjunctival Cyst

Datatyp

integer

Alias
UMLS CUI [1]
C0155170
Pterygium
Beskrivning

Pterygium

Datatyp

integer

Alias
UMLS CUI [1]
C0033999
Pinguecula
Beskrivning

Pinguecula

Datatyp

integer

Alias
UMLS CUI [1]
C0152255
Conjunctival Naevus
Beskrivning

Conjunctival Naevus

Datatyp

integer

Alias
UMLS CUI [1]
C0346363
12-Lead ECG
Beskrivning

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Beskrivning

Date of ECG

Datatyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
Time of ECG
Beskrivning

Time of ECG

Datatyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0040223
Result of ECG
Beskrivning

ECG must be repeated should any clinically significant abnormality/worsening be noted by the investigator post-randomisation or the ECG is flagged as unreadable by the central independent cardiologist. Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
Change in ECG result
Beskrivning

Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0392747
Tillbaka till toppen

Similar models

Nasal and Opthalmic Examination, Vital Signs, ECG - Visit 15

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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)
Item Group
Ophthalmic Examination
C0200149 (UMLS CUI-1)
Date of Ophthalmic Examination
Item
Date of Ophthalmic Examination
date
C0200149 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Opthalmic Examination
Item
Time of Opthalmic Examination
time
C0040223 (UMLS CUI [1,1])
C0200149 (UMLS CUI [1,2])
Name of Ophthalmologist/Optometrist
Item
Name of Ophthalmologist/Optometrist performing the examination
text
C1704292 (UMLS CUI [1,1])
C2826892 (UMLS CUI [1,2])
C1704292 (UMLS CUI [2,1])
C0029146 (UMLS CUI [2,2])
Item
Examined Side
text
C0441987 (UMLS CUI [1,1])
C0200149 (UMLS CUI [1,2])
Examined Side
Code List
Examined Side
CL Item
Left Eye (OS)
CL Item
Right Eye (OD)
Intraocular Pressure
Item
Intraocular Pressure
integer
C0578862 (UMLS CUI [1])
Item
Macula
integer
C0423419 (UMLS CUI [1])
Macula
Code List
Macula
CL Item
Normal (1)
CL Item
Abnormal (2)
Cup Disc
Item
Cup Disc
integer
C0278233 (UMLS CUI [1])
Item
Pigment/Naevus
integer
C0423417 (UMLS CUI [1])
Pigment/Naevus
Code List
Pigment/Naevus
CL Item
absent (0)
CL Item
present (1)
Item
Retinal Vessels
integer
C0035330 (UMLS CUI [1])
Macula
Code List
Retinal Vessels
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Exudates
integer
C0240897 (UMLS CUI [1])
Mucosal oedema left nostril
Code List
Exudates
CL Item
absent (0)
CL Item
present (1)
Item
Microaneurysms
integer
C0154834 (UMLS CUI [1])
Mucosal oedema left nostril
Code List
Microaneurysms
CL Item
absent (0)
CL Item
present (1)
Item
Retinal haemorrhage
integer
C0035317 (UMLS CUI [1])
Mucosal oedema left nostril
Code List
Retinal haemorrhage
CL Item
absent (0)
CL Item
present (1)
Item
Cornea
integer
C0010031 (UMLS CUI [1])
Macula
Code List
Cornea
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
If abnormal cornea, indicate if epithelial location.
text
C1855670 (UMLS CUI [1,1])
C0459875 (UMLS CUI [1,2])
Patency of Left Nostril
Code List
If abnormal cornea, indicate if epithelial location.
CL Item
Yes (Y)
CL Item
No (N)
Item
If abnormal cornea, indicate if stromal location.
text
C1855670 (UMLS CUI [1,1])
C0010040 (UMLS CUI [1,2])
Patency of Left Nostril
Code List
If abnormal cornea, indicate if stromal location.
CL Item
Yes (Y)
CL Item
No (N)
Item
If abnormal cornea, indicate if endothelial location.
text
C1855670 (UMLS CUI [1,1])
C0014259 (UMLS CUI [1,2])
Patency of Left Nostril
Code List
If abnormal cornea, indicate if endothelial location.
CL Item
Yes (Y)
CL Item
No (N)
Item
Iris
integer
C0022077 (UMLS CUI [1])
Macula
Code List
Iris
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Pupil
integer
C0034121 (UMLS CUI [1])
Macula
Code List
Pupil
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Cataract
text
C0086543 (UMLS CUI [1])
Patency of Left Nostril
Code List
Cataract
CL Item
Yes (Y)
CL Item
No (N)
Item
If there is a cataract present, indicate the type
integer
C0086543 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Cataract type
Code List
If there is a cataract present, indicate the type
CL Item
Cortical (1)
CL Item
Nuclear Sclerotic (2)
CL Item
Posterior subcapsular (3)
Item
If posterior subcapsular cataract, how extensive?
integer
C0858617 (UMLS CUI [1,1])
C0439792 (UMLS CUI [1,2])
Extent of posterior subcapsular cataract
Code List
If posterior subcapsular cataract, how extensive?
CL Item
Trace (1)
CL Item
Definite plaque (under 2 mm) (2)
CL Item
Definite plaque (2 mm or more) (3)
Item
Conjunctival Cyst
integer
C0155170 (UMLS CUI [1])
Pigment/Naevus
Code List
Conjunctival Cyst
CL Item
absent (0)
CL Item
present (1)
Item
Pterygium
integer
C0033999 (UMLS CUI [1])
Mucosal oedema left nostril
Code List
Pterygium
CL Item
absent (0)
CL Item
present (1)
Item
Pinguecula
integer
C0152255 (UMLS CUI [1])
Mucosal oedema left nostril
Code List
Pinguecula
CL Item
absent (0)
CL Item
present (1)
Item
Conjunctival Naevus
integer
C0346363 (UMLS CUI [1])
Mucosal oedema left nostril
Code List
Conjunctival Naevus
CL Item
absent (0)
CL Item
present (1)
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Date of ECG
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Result of ECG
integer
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
ECG Results
Code List
Result of ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
Item
Change in ECG result
integer
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
Change in ECG result
Code List
Change in ECG result
CL Item
Clinically significant change from baseline - favourable (1)
CL Item
Clinically significant change from baseline - unfavourable (2)
CL Item
No change or insignificant change from baseline (3)
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