ID

30192

Descripción

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 Examination, Vital Signs, ECG and Laboratory (Visit 1).

Palabras clave

Versiones (1)
  1. 18/5/18 18/5/18 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

18 de mayo de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

Nasal Examination, Vital Signs, ECG, Laboratory - Visit 1

1 formularios  
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Descripción

Height

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic Blood pressure
Descripción

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.

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood pressure
Descripción

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.

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

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.

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Nasal Examination
Descripción

Nasal Examination

Alias
UMLS CUI-1
C0558826
Left Nostril patent?
Descripción

Patency of Left Nostril

Tipo de datos

text

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

Patency of Right Nostril

Tipo de datos

text

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

Septum

Tipo de datos

text

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

Septum Deviation

Tipo de datos

integer

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

Mucosal oedema left nostril

Tipo de datos

integer

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

Mucosal oedema right nostril

Tipo de datos

integer

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

Crusting of left nasal Mucosa

Tipo de datos

integer

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

Crusting of right nasal Mucosa

Tipo de datos

integer

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

Bleeding of Left Nasal Mucosa

Tipo de datos

integer

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

Bleeding of right Nasal Mucosa

Tipo de datos

integer

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

Secretion from left nostril

Tipo de datos

integer

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

Color of Secretion from left nostril

Tipo de datos

integer

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

Secretion from right Nostril

Tipo de datos

integer

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

Color of Secretion from right Nostril

Tipo de datos

integer

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

Ulcers on left turbinates

Tipo de datos

integer

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

Ulcers on left nasal septum

Tipo de datos

integer

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

Ulcers on right turbinates

Tipo de datos

integer

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

Ulcers on right nasal septum

Tipo de datos

integer

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

Size of the largest polyp, if present

Tipo de datos

integer

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

Size of the largest polyp, if present

Tipo de datos

integer

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

Size of the largest polyp, if present

Tipo de datos

integer

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

Size of the largest polyp, if present

Tipo de datos

integer

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

Nasal Candidiasis Examination

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

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.

Tipo de datos

text

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

Nasal Swab taken

Tipo de datos

text

Alias
UMLS CUI [1]
C3669207
Nasal Swab result
Descripción

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.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3669207
UMLS CUI [1,2]
C1274040
12-Lead ECG
Descripción

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Descripción

Date of ECG

Tipo de datos

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Descripción

Time of ECG

Tipo de datos

time

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

If clinically significant abnormality, record medical condition in the (Past/current) Medical Conditions form.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0430456
Central Laboratory
Descripción

Central Laboratory

Alias
UMLS CUI-1
C1880016
Date Blood sample taken
Descripción

Date Blood sample taken

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Date urine sample taken (Urinalysis)
Descripción

Date urine sample taken

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
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Similar models

Nasal Examination, Vital Signs, ECG, Laboratory - Visit 1

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Height
Item
Height
integer
C0005890 (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
12-Lead ECG
C0430456 (UMLS CUI-1)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Result of ECG
integer
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Result of ECG
Code List
Result of ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
Item Group
Central Laboratory
C1880016 (UMLS CUI-1)
Date Blood sample taken
Item
Date Blood sample taken
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date urine sample taken
Item
Date urine sample taken (Urinalysis)
date
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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