ID

38666

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

Keywords

Versions (4)
  1. 11/5/18 11/5/18 -
  2. 11/5/18 11/5/18 -
  3. 12/4/18 12/4/18 -
  4. 10/30/19 10/30/19 - Sarah Riepenhausen
Copyright Holder

GSK group of companies

Uploaded on

October 30, 2019

DOI

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License

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

English

Concomitant Medications Form

1 forms  
Concomitant Medication Details
Description

Concomitant Medication Details

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C1522508
Sequence Number
Description

Sequence Number

Data type

text

Alias
UMLS CUI [1]
C2348184
Drug Name
Description

Trade Name Preferred

Data type

text

Alias
UMLS CUI [1]
C2360065
Unit Dose
Description

Unit Dose

Data type

integer

Alias
UMLS CUI [1]
C0869039
Units
Description

Units

Data type

text

Alias
UMLS CUI [1]
C1519795
Medication Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Medication Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Generic dispensed?
Description

Generic dispensed?

Data type

boolean

Alias
UMLS CUI [1,1]
C3242750
UMLS CUI [1,2]
C0947323
Prescription or OTC?
Description

Prescription or OTC?

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0033080
UMLS CUI [2]
C0013231
Medication Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Medication Taken prior to study?
Description

Taken prior to study?

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C0332152
Medication Ongoing?
Description

Ongoing?

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
If NO, record the End Date
Description

If NO, record the End Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Device Used to Administer Medication
Description

Device Used to Administer Medication

Data type

text

Alias
UMLS CUI [1]
C0699733
UMLS CUI [2]
C0013227
Total Daily Dose
Description

Total Daily Dose

Data type

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0439810
Was drug administered for an exacerbation?
Description

Was drug administered for an exacerbation?

Data type

boolean

Alias
UMLS CUI [1,1]
C0806914
UMLS CUI [1,2]
C0349790
Was drug administered as a rescue medication?
Description

Was drug administered as a rescue medication?

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0884980
Cumulative Dose Used?
Description

Cumulative Dose Used?

Data type

text

Alias
UMLS CUI [1]
C2986497
Was drug ever used?
Description

Was drug ever used?

Data type

boolean

Alias
UMLS CUI [1]
C0242510
Drug usage Total duration
Description

Total duration

Data type

text

Alias
UMLS CUI [1,1]
C0242510
UMLS CUI [1,2]
C0449238
Duration Unit
Description

Duration Unit

Data type

text

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1519795
Medication Type
Description

Medication Type

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332307
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Similar models

Concomitant Medications Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Concomitant Medication Details
C2347852 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Unit Dose
Item
Unit Dose
integer
C0869039 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Frequency
Item
Medication Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Generic dispensed?
Item
Generic dispensed?
boolean
C3242750 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
Item
Prescription or OTC?
text
C0013227 (UMLS CUI [1,1])
C0033080 (UMLS CUI [1,2])
C0013231 (UMLS CUI [2])
Prescription of OTC?
Code List
Prescription or OTC?
CL Item
Prescription (1)
CL Item
OTC (2)
Start Date
Item
Medication Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Taken prior to study?
Item
Medication Taken prior to study?
boolean
C0013227 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Ongoing?
Item
Medication Ongoing?
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
If NO, record the End Date
Item
If NO, record the End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Device Used to Administer Medication
Item
Device Used to Administer Medication
text
C0699733 (UMLS CUI [1])
C0013227 (UMLS CUI [2])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Was drug administered for an exacerbation?
Item
Was drug administered for an exacerbation?
boolean
C0806914 (UMLS CUI [1,1])
C0349790 (UMLS CUI [1,2])
Was drug administered as a rescue medication?
Item
Was drug administered as a rescue medication?
boolean
C0013227 (UMLS CUI [1,1])
C0884980 (UMLS CUI [1,2])
Cumulative Dose Used?
Item
Cumulative Dose Used?
text
C2986497 (UMLS CUI [1])
Was drug ever used?
Item
Was drug ever used?
boolean
C0242510 (UMLS CUI [1])
Total duration
Item
Drug usage Total duration
text
C0242510 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item
Duration Unit
text
C0449238 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Duration Unit
Code List
Duration Unit
CL Item
Days (1)
CL Item
Months (2)
CL Item
Weeks (3)
CL Item
Years (4)
Item
Medication Type
text
C0013227 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Medication Type
Code List
Medication Type
CL Item
Non-Asthma (1)
CL Item
Asthma (2)
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