ID

29542

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: Pneumonia Assessment

Stichworte

Versionen (2)
  1. 21.03.18 21.03.18 -
  2. 05.04.18 05.04.18 -
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GlaxoSmithKline

Hochgeladen am

5. April 2018

DOI

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Creative Commons BY-NC 3.0
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GSK Efficacy and safety of Fluticasone on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) NCT01009463

Englisch

Pneumonia Assessment

1 Formulare  
  1. StudyEvent: ODM
    1. Pneumonia Assessment
Pneumonia Assessment
Beschreibung

Pneumonia Assessment

Alias
UMLS CUI-1
C0032285
UMLS CUI-2
C0024117
UMLS CUI-3
C0220825
UMLS CUI-4
C0031809
Onset Date Pneumonia
Beschreibung

Onset Date Pneumonia

Datentyp

date

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0574845
Level of cough code
Beschreibung

Level of cough code

Datentyp

integer

Alias
UMLS CUI [1]
C0010200
Increased sputum purulence
Beschreibung

Increased sputum purulence

Datentyp

integer

Alias
UMLS CUI [1]
C0241235
Was the chest auscultation normal ?
Beschreibung

chest auscultation

Datentyp

integer

Alias
UMLS CUI [1]
C0577960
Dyspnea
Beschreibung

Dyspnea

Datentyp

integer

Alias
UMLS CUI [1]
C0013404
Culture/swab taken?
Beschreibung

Culture/swab taken?

Datentyp

boolean

Alias
UMLS CUI [1]
C0563454
Yes, culture swab taken, pathogen from pneumonia culture
Beschreibung

pathogen from pneumonia culture

Datentyp

integer

Alias
UMLS CUI [1,1]
C0450254
UMLS CUI [1,2]
C0200949
UMLS CUI [1,3]
C0032285
Pleural effusion location code
Beschreibung

Pleural effusion location code

Datentyp

integer

Alias
UMLS CUI [1,1]
C1253943
UMLS CUI [1,2]
C1515974
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • C
Alias
UMLS CUI [1]
C0005903
C
Respiration rate
Beschreibung

Respiration rate

Datentyp

integer

Maßeinheiten
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Blood pressure systolic
Beschreibung

Blood pressure systolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic
Beschreibung

Blood pressure diastolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Does subject have hypoxemia?
Beschreibung

hypoxemia

Datentyp

integer

Alias
UMLS CUI [1]
C0700292
Does subject have elevated WBC?
Beschreibung

elevated WBC

Datentyp

integer

Alias
UMLS CUI [1]
C0750426
Was this subject in a health care setting (inpatient) when the pneumonia developed?
Beschreibung

health care setting when the pneumonia developed

Datentyp

integer

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0086388
UMLS CUI [2]
C0205721
Was an x-ray performed?
Beschreibung

x-ray

Datentyp

boolean

Alias
UMLS CUI [1]
C0039985
Was subject hospitalised due to this diagnosis of pneumonia?
Beschreibung

hospitalisation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0032285
Did subject die as a result of the pneumonia?
Beschreibung

death as a result of the pneumonia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C0032285
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Ähnliche Modelle

Pneumonia Assessment

1 Formulare
  1. StudyEvent: ODM
    1. Pneumonia Assessment
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Pneumonia Assessment
C0032285 (UMLS CUI-1)
C0024117 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0031809 (UMLS CUI-4)
Onset Date Pneumonia
Item
Onset Date Pneumonia
date
C0032285 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Level of cough code
integer
C0010200 (UMLS CUI [1])
Level of cough code
Code List
Level of cough code
CL Item
Usual level of cough (1)
CL Item
Increased cough (2)
Item
Increased sputum purulence
integer
C0241235 (UMLS CUI [1])
Increased sputum purulence
Code List
Increased sputum purulence
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Was the chest auscultation normal ?
integer
C0577960 (UMLS CUI [1])
Increased sputum purulence
Code List
Was the chest auscultation normal ?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Dyspnea
integer
C0013404 (UMLS CUI [1])
Increased sputum purulence
Code List
Dyspnea
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Culture/swab taken?
Item
Culture/swab taken?
boolean
C0563454 (UMLS CUI [1])
Item
Yes, culture swab taken, pathogen from pneumonia culture
integer
C0450254 (UMLS CUI [1,1])
C0200949 (UMLS CUI [1,2])
C0032285 (UMLS CUI [1,3])
pathogen from pneumonia culture
Code List
Yes, culture swab taken, pathogen from pneumonia culture
CL Item
Streptococcus pneumoniae (1)
CL Item
Haemophilus influenza (2)
CL Item
Staphlococcus aureus (3)
CL Item
Streptococcus pyogenes (4)
CL Item
Klebsiella pneumoniae (5)
CL Item
Pseudomonas aeruginosa (6)
CL Item
Moraxella catarrhalis (7)
CL Item
Other (8)
Item
Pleural effusion location code
integer
C1253943 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Pleural effusion location code
Code List
Pleural effusion location code
CL Item
Right chest (1)
CL Item
Left chest (2)
CL Item
Bilateral (3)
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Respiration rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Blood pressure systolic
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure diastolic
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
Item
Does subject have hypoxemia?
integer
C0700292 (UMLS CUI [1])
Increased sputum purulence
Code List
Does subject have hypoxemia?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Does subject have elevated WBC?
integer
C0750426 (UMLS CUI [1])
Increased sputum purulence
Code List
Does subject have elevated WBC?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Was this subject in a health care setting (inpatient) when the pneumonia developed?
integer
C0032285 (UMLS CUI [1,1])
C0086388 (UMLS CUI [1,2])
C0205721 (UMLS CUI [2])
Increased sputum purulence
Code List
Was this subject in a health care setting (inpatient) when the pneumonia developed?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
x-ray
Item
Was an x-ray performed?
boolean
C0039985 (UMLS CUI [1])
hospitalisation
Item
Was subject hospitalised due to this diagnosis of pneumonia?
boolean
C0019993 (UMLS CUI [1,1])
C0032285 (UMLS CUI [1,2])
death as a result of the pneumonia
Item
Did subject die as a result of the pneumonia?
boolean
C0011065 (UMLS CUI [1,1])
C0032285 (UMLS CUI [1,2])
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