ID

30212

Beschreibung

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 Medical Conditions, Allergy History and Tests (Visit 1).

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Versionen (1)
  1. 18.05.18 18.05.18 - Sarah Riepenhausen
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GlaxoSmithKline

Hochgeladen am

18. Mai 2018

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

Englisch

Medical Conditions, Allergy History and Tests - Visit 1

1 Formulare  
Medical Conditions
Beschreibung

Medical Conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0262926
MedDRA System Organ Class
Beschreibung

MedDRA System Organ Class

Datentyp

integer

Alias
UMLS CUI [1]
C2347091
Medical History Status
Beschreibung

Medical History Status

Datentyp

integer

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0449438
Diagnosis of Rhinitis
Beschreibung

Diagnosis of Rhinitis

Alias
UMLS CUI-1
C2607914
In addition to a history of Perennial Allergic Rhinitis (PAR), does the subject have a history of Idiopathic/Vasomotor Rhinitis (VMR)?
Beschreibung

Idiopathic/Vasomotor Rhinitis (VMR)

Datentyp

text

Alias
UMLS CUI [1]
C0494650
In addition to a history of Perennial Allergic Rhinitis (PAR), does the subject have a history of Seasonal Allergic Rhinitis (SAR)?
Beschreibung

Seasonal Allergic Rhinitis (SAR)

Datentyp

text

Alias
UMLS CUI [1]
C0348688
Duration of perennial allergic rhinitis
Beschreibung

Duration of perennial allergic rhinitis

Alias
UMLS CUI-1
C0035457
UMLS CUI-2
C0449238
Duration of perennial allergic rhinitis
Beschreibung

Duration of perennial allergic rhinitis

Datentyp

integer

Alias
UMLS CUI [1,1]
C0035457
UMLS CUI [1,2]
C0449238
Allergen Test
Beschreibung

Allergen Test

Alias
UMLS CUI-1
C0430561
Diluent Control Wheal Diameter
Beschreibung

Diluent Control Wheal

Datentyp

float

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C3827475
UMLS CUI [1,2]
C0243148
UMLS CUI [1,3]
C0430561
mm
Tested Allergen
Beschreibung

Moulds, animal allergens or other

Datentyp

integer

Alias
UMLS CUI [1,1]
C0002092
UMLS CUI [1,2]
C0430561
Wheal diameter
Beschreibung

A positive allergen test reaction is defined as a wheal diameter that is 3mm greater than Diluent Control. If exact diameter not known, record comment on Investigator Comment Log page in this CRF

Datentyp

float

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C3827475
UMLS CUI [1,2]
C0430561
mm
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Ähnliche Modelle

Medical Conditions, Allergy History and Tests - Visit 1

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Medical Conditions
C0012634 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Item
MedDRA System Organ Class
integer
C2347091 (UMLS CUI [1])
MedDRA System Organ Class
Code List
MedDRA System Organ Class
CL Item
Blood and lymphatic system disorders (1)
CL Item
Cardiac disorders (2)
CL Item
Ear and labyrinth disorders (3)
CL Item
Endocrine disorders (4)
CL Item
Eye disorders (5)
CL Item
Gastrointestinal disorders (6)
CL Item
Hepatobiliary disorders (7)
CL Item
Immune system disorders (8)
CL Item
Metabolism and nutrition disorders (9)
CL Item
Musculoskeletal and connective tissue disorders (10)
CL Item
Neoplasms benign, malignant and unspecified (including cysts and polyps) (11)
CL Item
Nervous system disorders (12)
CL Item
Psychiatric disorders (13)
CL Item
Renal and urinary disorders (14)
CL Item
Reproductive system and breast disorders (15)
CL Item
Respiratory, thoracic and mediastinal disorders (16)
CL Item
Skin and subcutaneous tissue disorders (17)
CL Item
Vascular disorders (18)
CL Item
Infections and infestations (19)
CL Item
Congenital, familial and genetic disorders (20)
CL Item
General disorders and administration site conditions (21)
CL Item
Injury, poisoning and procedural complications (22)
CL Item
Investigations (23)
Item
Medical History Status
integer
C0262926 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Medical History Status
Code List
Medical History Status
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical History (3)
CL Item
Not Assessed (4)
Item Group
Diagnosis of Rhinitis
C2607914 (UMLS CUI-1)
Item
In addition to a history of Perennial Allergic Rhinitis (PAR), does the subject have a history of Idiopathic/Vasomotor Rhinitis (VMR)?
text
C0494650 (UMLS CUI [1])
Idiopathic/Vasomotor Rhinitis (VMR)
Code List
In addition to a history of Perennial Allergic Rhinitis (PAR), does the subject have a history of Idiopathic/Vasomotor Rhinitis (VMR)?
CL Item
Yes (Y)
CL Item
No (N)
Item
In addition to a history of Perennial Allergic Rhinitis (PAR), does the subject have a history of Seasonal Allergic Rhinitis (SAR)?
text
C0348688 (UMLS CUI [1])
Seasonal Allergic Rhinitis (SAR)
Code List
In addition to a history of Perennial Allergic Rhinitis (PAR), does the subject have a history of Seasonal Allergic Rhinitis (SAR)?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Duration of perennial allergic rhinitis
C0035457 (UMLS CUI-1)
C0449238 (UMLS CUI-2)
Item
Duration of perennial allergic rhinitis
integer
C0035457 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Duration of perennial allergic rhinitis
Code List
Duration of perennial allergic rhinitis
CL Item
2 or more, but less than 5 years (8)
CL Item
5 or more, but less than 10 years (11)
CL Item
more than 10 years (12)
Item Group
Allergen Test
C0430561 (UMLS CUI-1)
Diluent Control Wheal
Item
Diluent Control Wheal Diameter
float
C3827475 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
C0430561 (UMLS CUI [1,3])
Item
Tested Allergen
integer
C0002092 (UMLS CUI [1,1])
C0430561 (UMLS CUI [1,2])
Tested Allergen
Code List
Tested Allergen
CL Item
Alternaria mould (34)
CL Item
Cladosporium mould (35)
CL Item
other mould (36)
CL Item
Cat dander (37)
CL Item
Cockroaches (38)
CL Item
Dog dander (39)
CL Item
Dust mites (40)
CL Item
other (not in list) (41)
Wheal diameter
Item
Wheal diameter
float
C3827475 (UMLS CUI [1,1])
C0430561 (UMLS CUI [1,2])
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