ID

24610

Descrizione

Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

Keywords

versioni (1)
  1. 08/08/17 08/08/17 -
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8 agosto 2017

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Creative Commons BY-NC 3.0 Legacy
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non-serious adverse events salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

Inglese

non-serious adverse events salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 moduli  
Administrative Data
Descrizione

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descrizione

subject identifier

Tipo di dati

integer

Alias
UMLS CUI [1]
C2348585
NON-SERIOUS ADVERSE EVENTS (AE)
Descrizione

NON-SERIOUS ADVERSE EVENTS (AE)

Alias
UMLS CUI-1
C1518404
Did the subject experience any non-serious adverse events during the study?
Descrizione

non-serious adverse events

Tipo di dati

text

Alias
UMLS CUI [1]
C1518404
If "yes" to non-serious adverse events, record each event separately by fulfilling the following items.
Descrizione

If "yes" to non-serious adverse events, record each event separately by fulfilling the following items.

Alias
UMLS CUI-1
C1518404
Event
Descrizione

Diagnosis Only (if known) Otherwise Sign/Symptom

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0011900
Start Date
Descrizione

start date of non-serious adverse event

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
Outcome
Descrizione

outcome of non-serious adverse event

Tipo di dati

integer

Alias
UMLS CUI [1]
C1705586
End Date
Descrizione

end date of non-serious adverse event

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
Maximum Intensity
Descrizione

maximum intensity of non-serious adverse event

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Descrizione

change in investigational product dose due to non-serious AE

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1707811
Withdrawal
Descrizione

Did the subject withdraw from study as a result of this AE?

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Relationship to Investigational Product(s)
Descrizione

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1518404
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Similar models

non-serious adverse events salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
NON-SERIOUS ADVERSE EVENTS (AE)
C1518404 (UMLS CUI-1)
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1])
non-serious adverse events
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
If "yes" to non-serious adverse events, record each event separately by fulfilling the following items.
C1518404 (UMLS CUI-1)
diagnosis of non-serious adverse event
Item
Event
text
C1518404 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
start date of non-serious adverse event
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
outcome of non-serious adverse event
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
end date of non-serious adverse event
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
maximum intensity of non-serious adverse event
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
text
C1518404 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1707811 (UMLS CUI [1,3])
change in investigational product dose due to non-serious AE
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Item
Withdrawal
text
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
subject withdrawal due to non-serious AE
Code List
Withdrawal
CL Item
Yes (Y)
CL Item
No (N)
Item
Relationship to Investigational Product(s)
text
C0013230 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
non-serious AE caused by investigational product
Code List
Relationship to Investigational Product(s)
CL Item
Yes (Y)
CL Item
No (N)
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