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Fel:
ID
24614
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 (4)
- 2017-08-08 2017-08-08 -
- 2017-08-08 2017-08-08 -
- 2017-08-08 2017-08-08 -
- 2017-08-16 2017-08-16 -
Uppladdad den
8 augusti 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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serious adverse events salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470
serious adverse events salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470
Similar models
serious adverse events salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
subject identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
centre number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,2])
randomisation number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Item
Did the subject experience a serious adverse event during the study?
text
C1519255 (UMLS CUI [1])
Code List
Did the subject experience a serious adverse event during the study?
CL Item
Yes (Y)
CL Item
No (N)
diagnosis of serious adverse event
Item
Event
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
start date of serius adverse event
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
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 serious adverse event
Item
End date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
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 SAE
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1707811 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C1707811 (UMLS CUI [1,3])
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
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])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
Item
Relationship to Investigational Product(s)
text
C0013230 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
results in death
Item
Results in death
boolean
C0011065 (UMLS CUI [1])
life-threatening SAE
Item
Is life-threatening
boolean
C1517874 (UMLS CUI [1])
requires hospitalization
Item
Requires hospitalisation or prolongation of existing hospitalisation
boolean
C0019993 (UMLS CUI [1])
results in disability
Item
Results in disability/incapacity
boolean
C0231170 (UMLS CUI [1])
congenital abnormality
Item
Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1])
other diseases
Item
Other, specify
text
C2359476 (UMLS CUI [1])
date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (Male)
CL Item
Female (Female)
body weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
text
C0304229 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Code List
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown at this time (Unknown at this time)
CL Item
Not applicable (Not applicable)
Item Group
SAE: Section 5 Possible Causes of SAE Other Than Investigational Product(s
C3828190 (UMLS CUI-1)
disease under study
Item
Disease under study
boolean
C0012634 (UMLS CUI [1])
medical conditions
Item
Medical condition(s)
boolean
C0012634 (UMLS CUI [1])
lack of efficacy
Item
Lack of efficacy
boolean
C0235828 (UMLS CUI [1])
withdrawal of investigational products
Item
Withdrawal of investigational product(s
boolean
C2349954 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
concomitant medication
Item
Concomitant medication
boolean
C2347852 (UMLS CUI [1])
study subject participation status
Item
Activity related to study participation
boolean
C2348568 (UMLS CUI [1])
other reasons
Item
Other, specify
text
C3840932 (UMLS CUI [1])
medical conditions
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C0012634 (UMLS CUI [1])
date of onset of serious adverse event
Item
Date of Onset
date
C2985916 (UMLS CUI [1])
Item
Condition Present at Time of the SAE?
text
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Code List
Condition Present at Time of the SAE?
CL Item
Yes (Y)
CL Item
No (N)
date of last occurrence of medical condition
Item
If No, Date of Last Occurrence.
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
SAE: SECTION 7 Other RELEVANT Risk Factors
C0035648 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI-2)
risk factors for serious adverse events
Item
Record other risk factors for serious adverse events.
text
C0035648 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item Group
SAE: SECTION 8 RELEVANT Concomitant Medications
C2347852 (UMLS CUI-1)
drug name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
medication dose
Item
Dose
integer
C3174092 (UMLS CUI [1])
CL Item
Actuation (ACTU)
CL Item
Ampoule (AMP)
CL Item
Application (APP)
CL Item
Bottle (BOT)
CL Item
Cubic centimeter (CC)
CL Item
Capsule (CAP)
CL Item
Gram (G)
CL Item
Drops (GTT)
CL Item
International Units (IU)
CL Item
Litre (L)
CL Item
Litres per minute (L/MIN)
CL Item
Lozenge (LOZ)
CL Item
Microgram (MCG)
CL Item
Microgram per kilogram per minute (MCG/KG/MIN)
CL Item
Microlitre (MCL)
CL Item
Millimole (MMOL)
CL Item
Nebule (NEB)
CL Item
Puff (PUFF)
CL Item
Spray (SPR)
CL Item
Tablet (TAB)
CL Item
Tablespoon (TBLSP)
CL Item
Teaspoon (TSP)
CL Item
Percent (%)
CL Item
Unknown (UNK)
CL Item
1 X daily (OD/QD)
CL Item
2 X daily (BID)
CL Item
3 X daily (TID)
CL Item
4 X daily (QID)
CL Item
Continuous (CONT)
CL Item
Cumulative dose (CUM)
CL Item
Daily (D)
CL Item
Intermittent (INT)
CL Item
Not available (NA)
CL Item
At night (NOCT)
CL Item
Other (OTH)
CL Item
As required (PRN)
CL Item
Every hour (quaque hora) (QH)
CL Item
Every other day (QOD)
CL Item
Every night (quaque nocte) (QN)
CL Item
Single dose (SD)
CL Item
Immediately (STAT)
CL Item
Taper (TAP)
CL Item
Unknown (UNK)
CL Item
Intramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intranasal (IN)
CL Item
Injection (INJ)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Other (OTH)
CL Item
Oral (PO)
CL Item
Subcutaneous (SC)
CL Item
Topical (TP)
CL Item
Unknown (UNK)
CL Item
Yes (Y)
CL Item
No (N)
start date of medication
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
stop date of medication
Item
Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
indication of medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Item Group
SAE: SECTION 9 Details of Investigational Product(s) Run -in period
C0304229 (UMLS CUI-1)
start date of investigational products
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
stop date of investigational products
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Item Group
SAE: SECTION 9 Details of Investigational Product(s): Investigational product
C0304229 (UMLS CUI-1)
start date of investigational products
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
stop date of investigational products
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
start date of interruption of investigational products
Item
Start Date of Interruption
date
C0808070 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
C1512900 (UMLS CUI [1,3])
C1512900 (UMLS CUI [1,2])
C1512900 (UMLS CUI [1,3])
stop date of interruption of investigational products
Item
Stop Date of Interruption
date
C0806020 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
C1512900 (UMLS CUI [1,3])
C1512900 (UMLS CUI [1,2])
C1512900 (UMLS CUI [1,3])
Item Group
SAE: SECTION 9 Details of Investigational Product(s)
C0304229 (UMLS CUI-1)
Item
Was randomisation code broken at investigational site?
text
C0034656 (UMLS CUI [1])
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not applicable (Not applicable)
Item Group
SAE: SECTION 10 Details of RELEVANT Assessments
C1516048 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI-2)
diagnosis of serious adverse events
Item
Provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE.
text
C0011900 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item Group
SAE: SECTION 11 Narrative Remarks
C0947611 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI-2)
narrative description of the serious adverse event
Item
Provide a brief narrative description of the SAE and details of treatment given
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
investigator's signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
investigator's name
Item
Investigator’s name
text
C2826892 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])