ID

24608

Beschrijving

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

Trefwoorden

Versies (3)
  1. 06-08-17 06-08-17 -
  2. 08-08-17 08-08-17 -
  3. 08-08-17 08-08-17 -
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8 augustus 2017

DOI

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

Engels

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

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

subject identifier

Datatype

integer

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

NON-SERIOUS ADVERSE EVENTS (AE)

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

Examples of an AE includes • Significant or unexpected worsening or exacerbation of the condition/ indication under study. • Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition. • New condition(s) detected or diagnosed after investigational product administration even though it may have been present prior to the start of the study. • Signs, symptoms, or the clinical sequelae of a suspected interaction. • Signs, symptoms, or the clinical sequelae of a suspected overdose of either investigational product or a concomitant medication (overdose per se should not be reported as an AE/SAE). • Significant failure of expected pharmacological or biological action.

Datatype

text

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

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

Alias
UMLS CUI-1
C1518404
Event
Beschrijving

Diagnosis Only (if known) Otherwise Sign/Symptom

Datatype

text

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

start date of non-serious adverse event

Datatype

date

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

outcome of non-serious adverse event

Datatype

integer

Alias
UMLS CUI [1]
C1705586
End Date
Beschrijving

end date of non-serious adverse event

Datatype

date

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

maximum intensity of non-serious adverse event

Datatype

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
Beschrijving

change in investigational product dose due to non-serious AE

Datatype

text

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

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

Datatype

text

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

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

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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