ID

29166

Beschreibung

Study ID: 102871 Clinical Study ID: HZC102871 Study Title:HZC102871: A 52-week efficacy and safety study to compare the effect of three dosage strengths of Fluticasone Furoate/GW642444 Inhalation Powder with GW642444 on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01009463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Pulmonary Disease, Chronic Obstructive Documentation part: COPD Exacerbations

Stichworte

Versionen (1)
  1. 04.03.18 04.03.18 -
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GlaxoSmithKline

Hochgeladen am

4. März 2018

DOI

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Efficacy and safety of Fluticasone on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) GSK102871

Englisch

COPD Exacerbations

1 Formulare  
  1. StudyEvent: ODM
    1. COPD Exacerbations
COPD exacerbations
Beschreibung

COPD exacerbations

Alias
UMLS CUI-1
C0740304
Date of Onset
Beschreibung

Date of onset of COPD exacerbation

Datentyp

date

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0574845
Outcome
Beschreibung

outcome of COPD exacerbation

Datentyp

integer

Alias
UMLS CUI [1,1]
C0085565
UMLS CUI [1,2]
C0740304
Date of Resolution or Death
Beschreibung

date of resolution or death

Datentyp

date

Alias
UMLS CUI [1,1]
C2985858
UMLS CUI [1,2]
C0740304
UMLS CUI [2]
C1148348
Severity
Beschreibung

severity of COPD excerbation

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439793
UMLS CUI [1,2]
C0740304
Was the subject withdrawn due to this exacerbation?
Beschreibung

subject withdrawn due to this COPD exacerbation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0740304
Primary cause of exacerbation?
Beschreibung

Cause of COPD exacerbation

Datentyp

text

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0085978
Were systemic/oral corticosteroids taken for the exacerbation?
Beschreibung

systemic/oral corticosteroids

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0740304
Were antibiotics taken for the exacerbation?
Beschreibung

antibiotics

Datentyp

text

Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C0740304
Was the subject hospitalised due to this exacerbation?
Beschreibung

hospitalisation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0740304
Was rescue medication use increased due to the exacerbation?
Beschreibung

rescue medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0884980
UMLS CUI [1,3]
C0740304
Was an x-ray performed?
Beschreibung

x-ray

Datentyp

boolean

Alias
UMLS CUI [1]
C0011923
Contact Method/Treatment Site for Exacerbations
Beschreibung

Contact Method/Treatment Site for Exacerbations

Alias
UMLS CUI-1
C0740304
UMLS CUI-2
C0418981
UMLS CUI-3
C0332158
Number of home visits, Day
Beschreibung

Number of home visits, Day

Datentyp

integer

Alias
UMLS CUI [1,1]
C0020043
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0439228
Number of home visits, Night
Beschreibung

Number of home visits, Night

Datentyp

integer

Alias
UMLS CUI [1,1]
C0020043
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0240526
Number of physician office/practice visits
Beschreibung

Number of physician office/practice visits

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0031834
UMLS CUI [1,3]
C0449788
Number of urgent care/outpatient clinic visits
Beschreibung

Number of urgent care/outpatient clinic visits

Datentyp

integer

Alias
UMLS CUI [1,1]
C1551285
UMLS CUI [1,2]
C0008952
UMLS CUI [1,3]
C0449788
Number of emergency room visits
Beschreibung

Number of emergency room visits

Datentyp

integer

Alias
UMLS CUI [1,1]
C2114437
UMLS CUI [1,2]
C0449788
Number of inpatient hospitalisation days, ICU
Beschreibung

Number of inpatient hospitalisation days, ICU

Datentyp

integer

Alias
UMLS CUI [1,1]
C0420496
UMLS CUI [1,2]
C0021708
Number of inpatient hospitalisation days, General ward
Beschreibung

Number of inpatient hospitalisation days, General ward

Datentyp

integer

Alias
UMLS CUI [1,1]
C0420496
UMLS CUI [1,2]
C0043030
Exacerbation Medications
Beschreibung

Exacerbation Medications

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0740304
Drug name
Beschreibung

Medication name

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Dose
Beschreibung

Dose

Datentyp

text

Alias
UMLS CUI [1]
C3174092
Medication Units
Beschreibung

Medication Units

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0013227
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0013227
Start Date
Beschreibung

Medication Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013227
End Date
Beschreibung

Medication End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0013227
Medication Ongoing?
Beschreibung

Medication Ongoing

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
Medication Taken Prior to Study?
Beschreibung

Medication Taken Prior to Study

Datentyp

boolean

Alias
UMLS CUI [1]
C2826667
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Ähnliche Modelle

COPD Exacerbations

1 Formulare
  1. StudyEvent: ODM
    1. COPD Exacerbations
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
COPD exacerbations
C0740304 (UMLS CUI-1)
Date of onset of COPD exacerbation
Item
Date of Onset
date
C0740304 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Outcome
integer
C0085565 (UMLS CUI [1,1])
C0740304 (UMLS CUI [1,2])
outcome of COPD exacerbation
Code List
Outcome
CL Item
Resolved (1)
CL Item
Fatal (2)
CL Item
Not resolved (3)
date of resolution or death
Item
Date of Resolution or Death
date
C2985858 (UMLS CUI [1,1])
C0740304 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
Item
Severity
integer
C0439793 (UMLS CUI [1,1])
C0740304 (UMLS CUI [1,2])
severity of COPD excerbation
Code List
Severity
CL Item
moderate (2)
CL Item
severe (3)
CL Item
mild (1)
subject withdrawn due to this COPD exacerbation
Item
Was the subject withdrawn due to this exacerbation?
boolean
C0422727 (UMLS CUI [1,1])
C0740304 (UMLS CUI [1,2])
Cause of COPD exacerbation
Item
Primary cause of exacerbation?
text
C0740304 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
systemic/oral corticosteroids
Item
Were systemic/oral corticosteroids taken for the exacerbation?
boolean
C0038317 (UMLS CUI [1,1])
C0740304 (UMLS CUI [1,2])
antibiotics
Item
Were antibiotics taken for the exacerbation?
text
C0003232 (UMLS CUI [1,1])
C0740304 (UMLS CUI [1,2])
hospitalisation
Item
Was the subject hospitalised due to this exacerbation?
boolean
C0019993 (UMLS CUI [1,1])
C0740304 (UMLS CUI [1,2])
rescue medication
Item
Was rescue medication use increased due to the exacerbation?
boolean
C0013227 (UMLS CUI [1,1])
C0884980 (UMLS CUI [1,2])
C0740304 (UMLS CUI [1,3])
x-ray
Item
Was an x-ray performed?
boolean
C0011923 (UMLS CUI [1])
Item Group
Contact Method/Treatment Site for Exacerbations
C0740304 (UMLS CUI-1)
C0418981 (UMLS CUI-2)
C0332158 (UMLS CUI-3)
Number of home visits, Day
Item
Number of home visits, Day
integer
C0020043 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
Number of home visits, Night
Item
Number of home visits, Night
integer
C0020043 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0240526 (UMLS CUI [1,3])
Number of physician office/practice visits
Item
Number of physician office/practice visits
integer
C0545082 (UMLS CUI [1,1])
C0031834 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Number of urgent care/outpatient clinic visits
Item
Number of urgent care/outpatient clinic visits
integer
C1551285 (UMLS CUI [1,1])
C0008952 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Number of emergency room visits
Item
Number of emergency room visits
integer
C2114437 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of inpatient hospitalisation days, ICU
Item
Number of inpatient hospitalisation days, ICU
integer
C0420496 (UMLS CUI [1,1])
C0021708 (UMLS CUI [1,2])
Number of inpatient hospitalisation days, General ward
Item
Number of inpatient hospitalisation days, General ward
integer
C0420496 (UMLS CUI [1,1])
C0043030 (UMLS CUI [1,2])
Item Group
Exacerbation Medications
C0013227 (UMLS CUI-1)
C0740304 (UMLS CUI-2)
Medication name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
Medication Units
Item
Medication Units
text
C1519795 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medication Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medication End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medication Ongoing
Item
Medication Ongoing?
boolean
C2826666 (UMLS CUI [1])
Medication Taken Prior to Study
Item
Medication Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
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