ID
33115
Beschrijving
Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. This document contains the form of SAE. It has to be filled in if the subject has experienced an SAE.
Trefwoorden
Versies (1)
- 28-11-18 28-11-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
28 november 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877
Serious Adverse Event (SAE)
- StudyEvent: ODM
Beschrijving
Serious Adverse Event (SAE)
Alias
- UMLS CUI-1
- C1519255
Beschrijving
If YES, indicate following sections. A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death b) is life-threatening c) requires hospitalization or prolongation of existing hospitalization d) results in disability/incapacity e) a congenital anomaly/birth defect f) other 1) 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. 2) Inform GlaxoSmithKline: The investigator must inform GSK of serious adverse events by fax or telephone (fax preferred) within 24 hours of becoming aware of the event.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
Beschrijving
SECTION 1 Demography
Alias
- UMLS CUI-1
- C0011298
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Sex
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Race
Datatype
integer
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Serious Adverse Events
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Diagnosis only (if known) OR Serious signs / symptoms (list one per line). Enter only the diagnosis (if known); otherwise each serious sign and symptom should be entered on a separate line. If a diagnosis subsequently becomes available, then this should be entered and the signs and symptoms crossed out.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
Beschrijving
day month year. Record the date of onset of the first occurrence of the SAE.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Beschrijving
00:00-23:59. Record the exact time of onset of the SAE.
Datatype
time
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1519255
Beschrijving
Record the maximum intensity that occurred over the duration of the SAE. Amend the intensity if it increases.
Datatype
text
Alias
- UMLS CUI [1]
- C1710066
Beschrijving
All SAEs must be followed until the events are resolved, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was "Resolved", "Resolved with sequelae", or was "Fatal". If the SAE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as "Not resolved" Also enter "Not resolved" if the SAE was ongoing at the time of death, but was not the cause of death.
Datatype
text
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
day month year. Record the date of resolution or the date of death. If the event resolved with sequelae, enter the date the subject's medical condition stabilized. Leave blank if the event is "Not resolved".
Datatype
date
Alias
- UMLS CUI [1,1]
- C2985918
- UMLS CUI [1,2]
- C1148348
Beschrijving
00:00-23:59. Record the exact time of resolution of the SAE or the time of death.
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2699488
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [2]
- C1301931
Beschrijving
Indicate only for the specific event(s) that were directly responsible for the action taken with investigational product(s)· None: lnvestigational product(s) continue(s) even though an adverse event has occurred. Dose adjusted: Dose is increased or decreased for one or more investigational product(s). Temporarily interrupted: Administration of one or more investigational product(s) was stopped temporarily but then restarted. Permanently discontinued: Administration of one or more investigational product(s) was stopped permanently and not restarted. Not applicable: Subject was not receiving investigational product(s) when the event occurred (e.g., pre- or postdosing) or the subject died and there was no prior decision to discontinue investigational product(s).
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beschrijving
Indicate only the event(s) directly responsible for the subject's withdrawal as indicated on the End of Study Record page.
Datatype
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Beschrijving
It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. "A easonable possibility" is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence/arguments that may support "A reasonable possibility'' include, for example, a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concomitant illness, or relevant medical history, should also be considered.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1519255
Beschrijving
If you tick No, please fill in the non-serious AE form and not the SAE form! A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death b) is life-threatening c) requires hospitalization or prolongation of existing hospitalization d) results in disability/incapacity e) a congenital anomaly/birth defect f) other
Datatype
text
Alias
- UMLS CUI [1]
- C1710056
Beschrijving
SECTION 3 Possible Causes of SAE other than Investigational Product(s)
Alias
- UMLS CUI-1
- C0015127
- UMLS CUI-2
- C1519255
Beschrijving
Disease
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1519255
Beschrijving
Treatment failure
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0162643
- UMLS CUI [1,2]
- C1519255
Beschrijving
Withdrawal of investigational product(s)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1519255
Beschrijving
Concomitant disorder
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C1519255
Beschrijving
Concomitant disorder, specify
Datatype
text
Alias
- UMLS CUI [1]
- C0009488
Beschrijving
Concomitant medication
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519255
Beschrijving
Concomitant medication, specify
Datatype
text
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
(e.g., procedures)
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschrijving
Activity related to study participation, specify
Datatype
text
Alias
- UMLS CUI [1]
- C2348568
Beschrijving
Other causation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0015127
- UMLS CUI [1,3]
- C1519255
Beschrijving
Other, specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0015127
Beschrijving
SECTION 4 Seriousness of SAE
Alias
- UMLS CUI-1
- C1710056
Beschrijving
Death
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C1519255
Beschrijving
Send autopsy report when available.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C1518965
Beschrijving
NOTE: The term ‘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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1517874
- UMLS CUI [1,2]
- C1519255
Beschrijving
NOTE: In 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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2348993
- UMLS CUI [1,2]
- C1519255
Beschrijving
NOTE: The term disability means a substantial disruption of a person’s ability to conduct normal 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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3830477
- UMLS CUI [1,2]
- C1519255
Beschrijving
Congenital anomaly
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2826727
- UMLS CUI [1,2]
- C1519255
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0205394
Beschrijving
Other, specify
Datatype
text
Alias
- UMLS CUI [1]
- C0205394
Beschrijving
SECTION 5 Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0012634
Beschrijving
Past/Current disease, allergies, surgeries
Datatype
text
Alias
- UMLS CUI [1,1]
- C1444637
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [2,1]
- C0521116
- UMLS CUI [2,2]
- C0012634
- UMLS CUI [3]
- C0020517
- UMLS CUI [4]
- C0543467
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0574845
Beschrijving
Condition present at time of the SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1519255
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1519255
Beschrijving
SECTION 6 Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C0205394
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C1519255
Beschrijving
SECTION 7 Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C0013230
- UMLS CUI-2
- C1522508
Beschrijving
lnvestigational product
Datatype
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522508
Beschrijving
Treatment period
Datatype
integer
Alias
- UMLS CUI [1]
- C2347804
Beschrijving
Date of dose
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Beschrijving
SECTION 8 Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Beschrijving
(Trade name preferred)
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Drug Dose
Datatype
integer
Alias
- UMLS CUI [1]
- C0678766
Beschrijving
Dose unit
Datatype
text
Alias
- UMLS CUI [1]
- C0869039
Beschrijving
Frequency
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
Started pre-study
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C2347804
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Post-SAE, continuing
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0549178
- UMLS CUI [1,2]
- C0032756
- UMLS CUI [1,3]
- C1519255
Beschrijving
Conditions treated / indication
Datatype
text
Alias
- UMLS CUI [1]
- C2826696
Beschrijving
SECTION 9 Narrative / Comments
Alias
- UMLS CUI-1
- C0947611
- UMLS CUI-2
- C1519255
Beschrijving
This should include but not be limited to the following: • Any previous occurrences of this type of event • Any relevant non-serious adverse events that occurred prior to the SAE • The full clinical presentation and sequelae/evolution of the SAE • Any associated signs and symptoms of the SAE • Explain any possible causes of the SAE • Treatment for the SAE (including any specific medications administered or non-drug treatment) • Any other action taken for the management of the SAE or the subject • Duration and outcome of the SAE • If the SAE is associated with an overdose of investigational product(s), details of the amount of overdose and whether it was intentional or accidental.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0678257
Beschrijving
SECTION 10 Details of Relevant Assessments
Alias
- UMLS CUI-1
- C1261322
- UMLS CUI-2
- C1519255
Beschrijving
Provide details of any other assessments or supplementary investigations/examinations that were conducted as part of the subject’s care and/or based on clinical judgment of the likely causative factors of the SAE. This may include, but not be limited to: • Laboratory data. Always provide the reference range and baseline values (fax or mail pages if extensive supporting data) • Findings of ECGs, X-rays, etc. • Results of other diagnostic tests or assays • Key findings from hospital discharge or pathology reports
Datatype
text
Alias
- UMLS CUI [1,1]
- C1522508
- UMLS CUI [1,2]
- C0220825
Beschrijving
SECTION 11 Reporting Investigator
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1533716
Beschrijving
The reporting investigator (not the study nurse or study monitor) must sign and date the SAE page.
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Address
Datatype
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0008961
Beschrijving
Invetigator Signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Additional or follow-up information
Alias
- UMLS CUI-1
- C1533716
- UMLS CUI-2
- C1519255
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1546922
- UMLS CUI [1,2]
- C1519255
Similar models
Serious Adverse Event (SAE)
- StudyEvent: ODM
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1148348 (UMLS CUI [1,2])
C2699488 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1301931 (UMLS CUI [2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1518965 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0521116 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C1519255 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C3714536 (UMLS CUI [1,2])
C1522508 (UMLS CUI-2)
C1522508 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0032756 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1519255 (UMLS CUI-2)
C0678257 (UMLS CUI [1,2])
C1519255 (UMLS CUI-2)
C0220825 (UMLS CUI [1,2])
C1533716 (UMLS CUI-2)
C0008961 (UMLS CUI [1,2])
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
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