ID

32495

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2018-11-05 2018-11-05 -
  2. 2018-12-04 2018-12-04 -
Rättsinnehavare

GSK group of companies

Uppladdad den

5 november 2018

DOI

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Licens

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

Engelsk

Asthma/COPD Exacerbations

1 Formulär  
Asthma Exacerbations
Beskrivning

Asthma Exacerbations

Date of Onset
Beskrivning

Date of Onset

Datatyp

date

Outcome
Beskrivning

Outcome

Datatyp

text

End Date
Beskrivning

If FATAL, Date of Death

Datatyp

date

Was the subject withdrawn due to this exacerbation?
Beskrivning

Was the subject withdrawn due to this exacerbation?

Datatyp

boolean

Were systemic/oral corticosteroids taken for the exacerbation?
Beskrivning

Were systemic/oral corticosteroids taken for the exacerbation?

Datatyp

boolean

Was the subject hospitalised due to this exacerbation?
Beskrivning

Was the subject hospitalised due to this exacerbation?

Datatyp

boolean

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

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

Datatyp

boolean

Was the subject intubated for this exacerbation?
Beskrivning

Was the subject intubated for this exacerbation?

Datatyp

boolean

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

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

Datatyp

text

7. Other
Beskrivning

specify

Datatyp

text

Contact Method/Treatment Site for Exacerbations
Beskrivning

Contact Method/Treatment Site for Exacerbations

Number of home visits (Day)
Beskrivning

If non, enter 0 (zero)

Datatyp

integer

Number of home visits (Night)
Beskrivning

Number of home visits (Night)

Datatyp

integer

Number of physician office/practice visits
Beskrivning

If none, enter 0 (zero)

Datatyp

integer

Number of urgent care/outpatient clinic visit
Beskrivning

If none, enter 0 (zero)

Datatyp

integer

Number of emergency room visits
Beskrivning

If none, enter 0 (zero)

Datatyp

integer

Number of inpatient hospitalisation days
Beskrivning

If none, enter 0 (zero)

Datatyp

integer

Exacerbation Medications Entry
Beskrivning

Exacerbation Medications Entry

Sequence number
Beskrivning

Sequence number

Datatyp

integer

Drug Name
Beskrivning

Trade Name preferred

Datatyp

text

Unit Dose
Beskrivning

Unit Dose

Datatyp

text

Units
Beskrivning

Units

Datatyp

text

Frequency
Beskrivning

Frequency

Datatyp

text

Route
Beskrivning

Route

Datatyp

text

Start Date
Beskrivning

Start Date

Datatyp

date

Taken prior to study?
Beskrivning

Taken prior to study?

Datatyp

boolean

Ongoing?
Beskrivning

Ongoing?

Datatyp

boolean

if No, record End Date
Beskrivning

if No, record End Date

Datatyp

date

Medication Type
Beskrivning

Medication Type

Datatyp

text

Tillbaka till toppen

Similar models

Asthma/COPD Exacerbations

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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)
Tillbaka till toppen 

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