ID

30206

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 Examination, Vital Signs; Visit 11, Week 36, Day 253+/-2 days.

Mots-clés

Versions (1)
  1. 18/05/2018 18/05/2018 - Sarah Riepenhausen
Détendeur de droits

GlaxoSmithKline

Téléchargé le

18 mai 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Safety of once-daily administration of Fluticasone nasal spray in adults and adolescents with perennial allergic rhinitis GSK 102123

Anglais

Nasal Examination, Vital Signs - Visit 11

1 Formulaires  
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Description

Weight

Type de données

float

Unités de mesure
  • 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.

Type de données

integer

Unités de mesure
  • 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.

Type de données

integer

Unités de mesure
  • 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.

Type de données

integer

Unités de mesure
  • 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

Type de données

text

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

Patency of Right Nostril

Type de données

text

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

Septum

Type de données

text

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

Septum Deviation

Type de données

integer

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

Mucosal oedema left nostril

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

integer

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

Bleeding of right Nasal Mucosa

Type de données

integer

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

Secretion from left nostril

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

integer

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

Ulcers on left nasal septum

Type de données

integer

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

Ulcers on right turbinates

Type de données

integer

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

Ulcers on right nasal septum

Type de données

integer

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

Size of the largest polyp, if present

Type de données

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

Type de données

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

Type de données

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

Type de données

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.

Type de données

text

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

Nasal Swab taken

Type de données

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.

Type de données

integer

Alias
UMLS CUI [1,1]
C3669207
UMLS CUI [1,2]
C1274040
Retour au début de la page

Similar models

Nasal Examination, Vital Signs - Visit 11

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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)
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial