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ID
25964
Beschrijving
Randomised, open label, two period, crossover study to compare the steroid systemic exposure of Fluticasone Propionate (FP) from FP/Salmeterol (SALM) (500/50) DISKUS and Budesonide (BUD) from BUD/formoterol (FOR).(200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. Primary objective:To compare the exposure of the inhaled steroid fluticasone propionate (FP) and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation twice daily (b.i.d.) when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe chronic pulmonary obstructive disease (COPD) population. Secondary objectives:To compare the pharmacokinetics of FP and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation b.i.d. when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe COPD population and to explore further the pharmacokinetics of FP and budesonide.
Trefwoorden
Versies (3)
- 02-10-17 02-10-17 -
- 02-10-17 02-10-17 -
- 09-10-17 09-10-17 -
Houder van rechten
Glaxo Smith Kline
Geüploaded op
2 oktober 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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GSK Study ID 100807 Fluticasone Propionate from SERETIDE™ (500/50) DISKUS™ and Budesonide from Symbicort (200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. SAE Form and Investigator comment (Screening Visit)
SAE Form and Investigator comment (Screening Visit)
- StudyEvent: ODM
Similar models
SAE Form and Investigator comment (Screening Visit)
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Serious Adverse Event report
Item
Complete the Serious Adverse Event pages: A separate set of SAE pages should be used for each SAE. However, if at the time of initial reporting, multiple SAEs are apparent that are temporally and/or clinically related, then they can be reported on the same page. The investigator must inform GSK of serious adverse events by fax or telephone (fax preferred) within 24 hours of becoming aware of the event.
text
C3897642 (UMLS CUI [1])
Follow-up information SAE
Item
The investigator and others responsible for subject care should institute any supplementary investigations of SAEs based on their clinical judgment of the likely causative factors. This may include seeking a further opinion from a specialist in the field of the adverse event. GlaxoSmithKline may also request extra tests or extra follow-up information. If a subject dies, any postmortem findings, including histopathology, must be provided to GlaxoSmithKline. On receipt of follow-up information (e.g., diagnosis, dates of resolution, changes in intensity or causality) the appropriate SAE pages must be amended/updated. These changes must be initialed and dated by the investigator. A copy of the full set of SAE pages must always be faxed or mailed to GlaxoSmithKline within 24 hours of the investigator becoming aware of the new information.
text
C0807975 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event Definition
Item
A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death b) is life-threatening NOTE:The tenn 'life-threatening' in the definition of 'serious· refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe. c) requires hospitalization or prolongation of existing hospitalization NOTE:ln general, hospitalization signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician's office or outpatient setting. Complications that occur during hospitalization are AEs. If a complication prolongs hospitalization or fulfills any other serious criteria, the event is serious. When in doubt as to whether "hospitalization" occurred or was necessary, the AE should be considered serious. Hospitalization for elective treatment of a pre-existing condition that did not worsen from baseline is not considered an AE. d) results in disability/incapacity NOTE:The term disability means a substantial disruption of a person's ability to conduct nonnal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and accidental trauma (e.g., sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption. e) a congenital anomaly/birth defect f) other Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, or development of drug dependency or drug abuse.
text
C1519255 (UMLS CUI [1,1])
C1704788 (UMLS CUI [1,2])
C1704788 (UMLS CUI [1,2])
Investigator Identifier
Item
Investigator number
integer
C2826689 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Did the subject experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1])
Code List
Did the subject experience any serious adverse events during the study?
CL Item
No (N)
CL Item
Yes (Y)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
CL Item
White (1)
CL Item
Black (2)
CL Item
Asian (3)
CL Item
Other (4)
Patient Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Patient Height
Item
Height
float
C0489786 (UMLS CUI [1])
Serious Adverse Events
Item
Event Diagnose only (if known) otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1])
Serious Adverse Event Onset Date
Item
Date of onset
date
C1519255 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
SAE onset time
Item
Time of onset
time
C1519255 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
CL Item
Resolved (R)
CL Item
Resolved with Sequelae (S)
CL Item
Fatal (F)
CL Item
Not Resolved (N)
Date of resolution or death
Item
Date of resolution or death
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Time of resolution or death
Item
Time of resolution or death
time
C0040223 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1301931 (UMLS CUI [1,4])
C2699488 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1301931 (UMLS CUI [1,4])
CL Item
none (1)
CL Item
Dose adjusted (2)
CL Item
Temporarily interrupted (3)
CL Item
Permanently discontinued (4)
CL Item
Not applicable (x)
Item
Did subject withdraw from study as a result of this SAE?
text
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
No (N)
CL Item
Yes (Y)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Code List
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
CL Item
No (N)
CL Item
Yes (Y)
Item
Does the AE meet the definition of serious?
text
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
CL Item
No (N)
CL Item
Yes (Y)
Item
Possible Causes of SAE Other Than lnvestigational Product(s)
integer
C1519255 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
CL Item
Disease under study (1)
CL Item
Concomitant disorder (specify) (2)
CL Item
Treatment failure (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication (specify) (5)
CL Item
Activity related to study participation (e.g. , procedures,specify) (6)
CL Item
Other, specify (7)
CL Item
Results in death (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other,please specify (F)
autopsy done
Item
If fatal was an autopsy done/to be performed?
boolean
C0004398 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
RELEVANT Medical Conditions
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Serious Adverse Event Onset Date
Item
Date of Onset
date
C0574845 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item
Condition Present at Time of the SAE?
text
C3827351 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
No (N)
CL Item
Yes (Y)
Other relevant risk factors
Item
Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
text
C0035648 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
lnvestigational Product
Item
Details of lnvestigational Product(s)
text
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
Relevant Concomitant Medications
Item
RELEVANT Concomitant Medications
text
C2347852 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Drug name
Item
Drug name (Trade name preferred)
text
C2347852 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Medication Dose
Item
Dose
integer
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Frequency
Item
Frequency (e.g. BID)
text
C3476109 (UMLS CUI [1])
Administration Route
Item
Route
text
C0013153 (UMLS CUI [1])
Medication Start Date
Item
Date Started
date
C2826734 (UMLS CUI [1])
Started Pre-Study
Item
Started Pre-Study
boolean
C0013227 (UMLS CUI [1,1])
C0451613 (UMLS CUI [1,2])
C0451613 (UMLS CUI [1,2])
Medication End Date
Item
Date Stopped
date
C1521826 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Ongoing Medication
Item
Medication continued post-SAE
boolean
C2826666 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Reason for Medication
Item
Conditions treated/indication
text
C2826696 (UMLS CUI [1])
Comments
Item
Narrative/Comments
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Assessments
Item
Details of RELEVANT Assessments
text
C0220825 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Reporting Investigator
Item
To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
boolean
C0008961 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C1533716 (UMLS CUI [1,2])
Reporting Investigator
Item
To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
boolean
C0008961 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C1533716 (UMLS CUI [1,2])
Investigator Name
Item
Name (print)
text
C2826892 (UMLS CUI [1])
Investigator Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
Investigator Signature
Item
Signature
text
C2346576 (UMLS CUI [1])
Date of completion
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0850287 (UMLS CUI [1,2])
C0850287 (UMLS CUI [1,2])
Additional or follow-up information
Item
Use this page to provide any additional details on the serious adverse event not already captured on the previous pages The appropriate section(s) (1-11) of SAE CRF must be amended/updated with any changes and re-faxed/mailed.
text
C1533716 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Investigator Name
Item
Name (print)
text
C2826892 (UMLS CUI [1])
Investigator Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
Investigator Signature
Item
Signature
text
C2346576 (UMLS CUI [1])
Date of completion
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0850287 (UMLS CUI [1,2])
C0850287 (UMLS CUI [1,2])
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
C0947611 (UMLS CUI-2)
Monitor Data Validation Checks
Item
If CRF page numbers are listed, check that they correspond to the documented comment.
text
C1519941 (UMLS CUI [1])
Investigator Comment Log
Item
Use this form to document any other relevant information that is not noted elsewhere in the CRF.
text
C0008961 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Date of comment
Item
Date of comment
date
C0947611 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CRF page number if applicable
Item
CRF page number if applicable
integer
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Investigators Statement
Item
I confirm that I have carefully examined all entries on the Screening Case Report Form for this subject. All infom,ation entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
boolean
C0008961 (UMLS CUI [1,1])
C1710187 (UMLS CUI [1,2])
C1710187 (UMLS CUI [1,2])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Investigator Name
Item
Investigator Name - print
text
C2826892 (UMLS CUI [1])
Date of completion
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0850287 (UMLS CUI [1,2])
C0850287 (UMLS CUI [1,2])