ID

32495

Beschreibung

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

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Versionen (2)
  1. 05.11.18 05.11.18 -
  2. 04.12.18 04.12.18 -
Rechteinhaber

GSK group of companies

Hochgeladen am

5. November 2018

DOI

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

Englisch

Asthma/COPD Exacerbations

1 Formulare  
Asthma Exacerbations
Beschreibung

Asthma Exacerbations

Date of Onset
Beschreibung

Date of Onset

Datentyp

date

Outcome
Beschreibung

Outcome

Datentyp

text

End Date
Beschreibung

If FATAL, Date of Death

Datentyp

date

Was the subject withdrawn due to this exacerbation?
Beschreibung

Was the subject withdrawn due to this exacerbation?

Datentyp

boolean

Were systemic/oral corticosteroids taken for the exacerbation?
Beschreibung

Were systemic/oral corticosteroids taken for the exacerbation?

Datentyp

boolean

Was the subject hospitalised due to this exacerbation?
Beschreibung

Was the subject hospitalised due to this exacerbation?

Datentyp

boolean

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

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

Datentyp

boolean

Was the subject intubated for this exacerbation?
Beschreibung

Was the subject intubated for this exacerbation?

Datentyp

boolean

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

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

Datentyp

text

7. Other
Beschreibung

specify

Datentyp

text

Contact Method/Treatment Site for Exacerbations
Beschreibung

Contact Method/Treatment Site for Exacerbations

Number of home visits (Day)
Beschreibung

If non, enter 0 (zero)

Datentyp

integer

Number of home visits (Night)
Beschreibung

Number of home visits (Night)

Datentyp

integer

Number of physician office/practice visits
Beschreibung

If none, enter 0 (zero)

Datentyp

integer

Number of urgent care/outpatient clinic visit
Beschreibung

If none, enter 0 (zero)

Datentyp

integer

Number of emergency room visits
Beschreibung

If none, enter 0 (zero)

Datentyp

integer

Number of inpatient hospitalisation days
Beschreibung

If none, enter 0 (zero)

Datentyp

integer

Exacerbation Medications Entry
Beschreibung

Exacerbation Medications Entry

Sequence number
Beschreibung

Sequence number

Datentyp

integer

Drug Name
Beschreibung

Trade Name preferred

Datentyp

text

Unit Dose
Beschreibung

Unit Dose

Datentyp

text

Units
Beschreibung

Units

Datentyp

text

Frequency
Beschreibung

Frequency

Datentyp

text

Route
Beschreibung

Route

Datentyp

text

Start Date
Beschreibung

Start Date

Datentyp

date

Taken prior to study?
Beschreibung

Taken prior to study?

Datentyp

boolean

Ongoing?
Beschreibung

Ongoing?

Datentyp

boolean

if No, record End Date
Beschreibung

if No, record End Date

Datentyp

date

Medication Type
Beschreibung

Medication Type

Datentyp

text

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Ähnliche Modelle

Asthma/COPD Exacerbations

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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