ID

32495

Description

Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Mots-clés

Versions (2)
  1. 05/11/2018 05/11/2018 -
  2. 04/12/2018 04/12/2018 -
Détendeur de droits

GSK group of companies

Téléchargé le

5 novembre 2018

DOI

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Licence

Creative Commons BY-NC 3.0
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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837

Anglais

Asthma/COPD Exacerbations

1 Formulaires  
Asthma Exacerbations
Description

Asthma Exacerbations

Date of Onset
Description

Date of Onset

Type de données

date

Outcome
Description

Outcome

Type de données

text

End Date
Description

If FATAL, Date of Death

Type de données

date

Was the subject withdrawn due to this exacerbation?
Description

Was the subject withdrawn due to this exacerbation?

Type de données

boolean

Were systemic/oral corticosteroids taken for the exacerbation?
Description

Were systemic/oral corticosteroids taken for the exacerbation?

Type de données

boolean

Was the subject hospitalised due to this exacerbation?
Description

Was the subject hospitalised due to this exacerbation?

Type de données

boolean

Did the subject visit the emergency room due to this exacerbation?
Description

Did the subject visit the emergency room due to this exacerbation?

Type de données

boolean

Was the subject intubated for this exacerbation?
Description

Was the subject intubated for this exacerbation?

Type de données

boolean

Which of the following lead to the diagnosis of a severe asthma exacerbation?
Description

Which of the following lead to the diagnosis of a severe asthma exacerbation?

Type de données

text

7. Other
Description

specify

Type de données

text

Contact Method/Treatment Site for Exacerbations
Description

Contact Method/Treatment Site for Exacerbations

Number of home visits (Day)
Description

If non, enter 0 (zero)

Type de données

integer

Number of home visits (Night)
Description

Number of home visits (Night)

Type de données

integer

Number of physician office/practice visits
Description

If none, enter 0 (zero)

Type de données

integer

Number of urgent care/outpatient clinic visit
Description

If none, enter 0 (zero)

Type de données

integer

Number of emergency room visits
Description

If none, enter 0 (zero)

Type de données

integer

Number of inpatient hospitalisation days
Description

If none, enter 0 (zero)

Type de données

integer

Exacerbation Medications Entry
Description

Exacerbation Medications Entry

Sequence number
Description

Sequence number

Type de données

integer

Drug Name
Description

Trade Name preferred

Type de données

text

Unit Dose
Description

Unit Dose

Type de données

text

Units
Description

Units

Type de données

text

Frequency
Description

Frequency

Type de données

text

Route
Description

Route

Type de données

text

Start Date
Description

Start Date

Type de données

date

Taken prior to study?
Description

Taken prior to study?

Type de données

boolean

Ongoing?
Description

Ongoing?

Type de données

boolean

if No, record End Date
Description

if No, record End Date

Type de données

date

Medication Type
Description

Medication Type

Type de données

text

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Similar models

Asthma/COPD Exacerbations

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Asthma Exacerbations
Date of Onset
Item
Date of Onset
date
Item
Outcome
text
Outcome
Code List
Outcome
CL Item
Resolved (1)
CL Item
Fatal (2)
CL Item
Not resolved (3)
End Date
Item
End Date
date
Was the subject withdrawn due to this exacerbation?
Item
Was the subject withdrawn due to this exacerbation?
boolean
Were systemic/oral corticosteroids taken for the exacerbation?
Item
Were systemic/oral corticosteroids taken for the exacerbation?
boolean
Was the subject hospitalised due to this exacerbation?
Item
Was the subject hospitalised due to this exacerbation?
boolean
Did the subject visit the emergency room due to this exacerbation?
Item
Did the subject visit the emergency room due to this exacerbation?
boolean
Was the subject intubated for this exacerbation?
Item
Was the subject intubated for this exacerbation?
boolean
Item
Which of the following lead to the diagnosis of a severe asthma exacerbation?
text
Which of the following lead to the diagnosis of a severe asthma exacerbation?
Code List
Which of the following lead to the diagnosis of a severe asthma exacerbation?
CL Item
Worsening daytime symptoms (1)
CL Item
Worsening nighttime symptoms (2)
CL Item
Decreasing peak flow (3)
CL Item
Decreasing FEV1 (4)
CL Item
Increasing rescue medication use (5)
CL Item
Clinical examination (e.g., increased wheezing heard with stethoscope) (6)
7. Other
Item
7. Other
text
Item Group
Contact Method/Treatment Site for Exacerbations
Number of home visits (Day)
Item
Number of home visits (Day)
integer
Number of home visits (Night)
Item
Number of home visits (Night)
integer
Number of physician office/practice visits
Item
Number of physician office/practice visits
integer
Number of urgent care/outpatient clinic visit
Item
Number of urgent care/outpatient clinic visit
integer
Number of emergency room visits
Item
Number of emergency room visits
integer
Number of inpatient hospitalisation days
Item
Number of inpatient hospitalisation days
integer
Item Group
Exacerbation Medications Entry
Sequence number
Item
Sequence number
integer
Drug Name
Item
Drug Name
text
Unit Dose
Item
Unit Dose
text
Item
Units
text
Units
Code List
Units
CL Item
Capsule (CAP) (1)
CL Item
Gram (G) (2)
CL Item
Litre (L) (3)
CL Item
Microgram (MCG) (4)
CL Item
Microlitre (MGL) (5)
CL Item
Miligram (MG) (6)
CL Item
Mililite (ML) (7)
CL Item
Tablet (TAB) (8)
CL Item
Unknown (UNK) (9)
Frequency
Item
Frequency
text
Item
Route
text
Route
Code List
Route
CL Item
Inhalation (1)
CL Item
Intramuscular (2)
CL Item
Intranasal (3)
CL Item
Injection (4)
CL Item
Intravenous (5)
CL Item
Nasal (6)
CL Item
Other (7)
CL Item
Oral (8)
CL Item
Subcutaneous (9)
Start Date
Item
Start Date
date
Taken prior to study?
Item
Taken prior to study?
boolean
Ongoing?
Item
Ongoing?
boolean
if No, record End Date
Item
if No, record End Date
date
Item
Medication Type
text
Medication Type
Code List
Medication Type
CL Item
Asthma Med (1)
CL Item
COPD Med (2)
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