ID

30211

Description

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.

Keywords

Versions (1)
  1. 5/18/18 5/18/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

May 18, 2018

DOI

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License

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

English

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

1 forms  
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic Blood pressure
Description

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.

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood pressure
Description

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.

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

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.

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Nasal Examination
Description

Nasal Examination

Alias
UMLS CUI-1
C0558826
Left Nostril patent?
Description

Patency of Left Nostril

Data type

text

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

Patency of Right Nostril

Data type

text

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

Septum

Data type

text

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

Septum Deviation

Data type

integer

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

Mucosal oedema left nostril

Data type

integer

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

Mucosal oedema right nostril

Data type

integer

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

Crusting of left nasal Mucosa

Data type

integer

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

Crusting of right nasal Mucosa

Data type

integer

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

Bleeding of Left Nasal Mucosa

Data type

integer

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

Bleeding of right Nasal Mucosa

Data type

integer

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

Secretion from left nostril

Data type

integer

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

Color of Secretion from left nostril

Data type

integer

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

Secretion from right Nostril

Data type

integer

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

Color of Secretion from right Nostril

Data type

integer

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

Ulcers on left turbinates

Data type

integer

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

Ulcers on left nasal septum

Data type

integer

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

Ulcers on right turbinates

Data type

integer

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

Ulcers on right nasal septum

Data type

integer

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

Size of the largest polyp, if present

Data type

integer

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

Size of the largest polyp, if present

Data type

integer

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

Size of the largest polyp, if present

Data type

integer

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

Size of the largest polyp, if present

Data type

integer

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

Nasal Candidiasis Examination

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

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.

Data type

text

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

Nasal Swab taken

Data type

text

Alias
UMLS CUI [1]
C3669207
Nasal Swab result
Description

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.

Data type

integer

Alias
UMLS CUI [1,1]
C3669207
UMLS CUI [1,2]
C1274040
Ophthalmic Examination
Description

Ophthalmic Examination

Alias
UMLS CUI-1
C0200149
Date of Ophthalmic Examination
Description

Answer once

Data type

date

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

Answer once

Data type

time

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

Answer once

Data type

text

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

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

Data type

text

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

Tonometry (Goldmann Applanation)

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0578862
mmHg
Macula
Description

Macula

Data type

integer

Alias
UMLS CUI [1]
C0423419
Cup Disc
Description

Cup Disc

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0278233
%
Pigment/Naevus
Description

Pigment/Naevus

Data type

integer

Alias
UMLS CUI [1]
C0423417
Retinal Vessels
Description

Retinal Vessels

Data type

integer

Alias
UMLS CUI [1]
C0035330
Exudates
Description

Exudates

Data type

integer

Alias
UMLS CUI [1]
C0240897
Microaneurysms
Description

Microaneurysms

Data type

integer

Alias
UMLS CUI [1]
C0154834
Retinal haemorrhage
Description

Retinal haemorrhage

Data type

integer

Alias
UMLS CUI [1]
C0035317
Cornea
Description

Cornea

Data type

integer

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

Epithelial Abnormality of Cornea

Data type

text

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

Stromal Abnormality of Cornea

Data type

text

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

Endothelial Abnormality of Cornea

Data type

text

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

Iris

Data type

integer

Alias
UMLS CUI [1]
C0022077
Pupil
Description

Pupil

Data type

integer

Alias
UMLS CUI [1]
C0034121
Cataract
Description

Cataract

Data type

text

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

Cataract type

Data type

integer

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

Extent of posterior subcapsular cataract

Data type

integer

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

Conjunctival Cyst

Data type

integer

Alias
UMLS CUI [1]
C0155170
Pterygium
Description

Pterygium

Data type

integer

Alias
UMLS CUI [1]
C0033999
Pinguecula
Description

Pinguecula

Data type

integer

Alias
UMLS CUI [1]
C0152255
Conjunctival Naevus
Description

Conjunctival Naevus

Data type

integer

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

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Description

Date of ECG

Data type

date

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

Time of ECG

Data type

time

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

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.

Data type

integer

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

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.

Data type

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0392747
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Nasal and Opthalmic Examination, Vital Signs, ECG - Visit 15

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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