ID

24610

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2017-08-08 2017-08-08 -
Uppladdad den

8 augusti 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0 Legacy
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

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

Engelsk

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

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

subject identifier

Datatyp

integer

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

NON-SERIOUS ADVERSE EVENTS (AE)

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

non-serious adverse events

Datatyp

text

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

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

Alias
UMLS CUI-1
C1518404
Event
Beskrivning

Diagnosis Only (if known) Otherwise Sign/Symptom

Datatyp

text

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

start date of non-serious adverse event

Datatyp

date

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

outcome of non-serious adverse event

Datatyp

integer

Alias
UMLS CUI [1]
C1705586
End Date
Beskrivning

end date of non-serious adverse event

Datatyp

date

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

maximum intensity of non-serious adverse event

Datatyp

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
Beskrivning

change in investigational product dose due to non-serious AE

Datatyp

text

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

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

Datatyp

text

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

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

Datatyp

text

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1518404
Tillbaka till toppen

Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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)
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial