ID

33028

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 Non-Serious Adverse Events form. It has to be filled in if a Non-Serious Adverse Event occurs during study. Examples of an AE includes: Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition. New conditions 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). Examples of an AE does NOT include a/an: Medical or surgical procedure (e.g., endoscopy, appendectomy); the condition that leads to the procedure is an AE. Situations where an untoward medical occurrence did not occur (social and/or convenience admission to a hospital). Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or detected at the start of the study that do not worsen. The disease/disorder being studied, or expected progression, signs, or symptoms of the disease/disorder being studied, unless more severe than expected for the sub1ect's condition.

Trefwoorden

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  1. 22-11-18 22-11-18 -
  2. 23-11-18 23-11-18 -
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GlaxoSmithKline

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23 november 2018

DOI

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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

Engels

Non-Serious Adverse Events

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Session Number
Beschrijving

Session Number

Datatype

integer

Alias
UMLS CUI [1,1]
C1883017
UMLS CUI [1,2]
C0750480
Non-Serious Adverse Events
Beschrijving

Non-Serious Adverse Events

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

If YES, indicate following items. Any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse.

Datatype

text

Alias
UMLS CUI [1]
C1518404
Non-serious adverse event, Diagnosis
Beschrijving

Diagnosis only (if known) signs / symptoms (list one per line). Enter only the diagnosis (if known); otherwise each 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]
C1518404
UMLS CUI [1,2]
C0011900
Date of onset
Beschrijving

day month year. Record the date of onset of the first occurrence of the AE .

Datatype

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1518404
Time of onset
Beschrijving

00:00-23:59 Record the exact time of onset of the AE.

Datatype

time

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1518404
Maximum intensity
Beschrijving

Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases.

Datatype

text

Alias
UMLS CUI [1]
C1710066
Outcome
Beschrijving

All AEs 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" or "Resolved with sequelae". If the adverse event 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 AE was ongoing at the time of death, but was not the cause of death.

Datatype

text

Alias
UMLS CUI [1]
C1705586
Date of resolution
Beschrijving

day month year. Record the date of resolution. This is the last date of occurrence of the AE. If the event resolved with sequelae, enter the date the subject's medical cond ition stabilized. Leave blank if the AE is "Not resolved".

Datatype

date

Alias
UMLS CUI [1]
C2985918
Time of resolution
Beschrijving

00:00-23:59 Record the exact lime of resolution of the AE.

Datatype

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2699488
UMLS CUI [1,3]
C1518404
Action taken with investigational Relationship product(s) as a result of the non-serious AE
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 investigation al product(s). Temporarily interrupted: Administration of one or more invesligational product(s) was stopped temporarily but then restarted. Permanently discontinued: Administration of one or more investigalional 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).

Datatype

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did subject withdraw from study as a result of non-serious AE?
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]
C1518404
Is there a reasonable possibility the non-serious AE may have been caused by the investigational product(s)?
Beschrijving

II is a regulatory requirement for investigators lo assess relationship lo invesligalional product(s) based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. "A reasonable 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]
C1518404
Does the AE meet the definition of serious?
Beschrijving

If you tick YES, fill in the SAE form!

Datatype

text

Alias
UMLS CUI [1]
C1710056
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Similar models

Non-Serious Adverse Events

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Session Number
integer
C1883017 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Session Number
Code List
Session Number
CL Item
Session 1 (1)
CL Item
Session 2 (2)
CL Item
Session 3 (3)
CL Item
Session 4 (4)
CL Item
Session 5 (5)
CL Item
Session 6 (6)
Item Group
Non-Serious Adverse Events
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 Event
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Non-serious adverse event, Diagnosis
Item
Non-serious adverse event, Diagnosis
text
C1518404 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Time of onset
Item
Time of onset
time
C0449244 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum intensity
text
C1710066 (UMLS CUI [1])
Maximum intensity
Code List
Maximum intensity
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe with  (3)
CL Item
Not applicable (X)
Item
Outcome
text
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Resolved (R)
CL Item
Resolved with sequelae (S)
CL Item
Not resolved (N)
Date of resolution
Item
Date of resolution
date
C2985918 (UMLS CUI [1])
Time of resolution
Item
Time of resolution
time
C0040223 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Action taken with investigational Relationship product(s) as a result of the non-serious AE
text
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Investigational product(s) as a result of the non-serious AE
Code List
Action taken with investigational Relationship product(s) as a result of the non-serious AE
CL Item
None (0)
CL Item
Dose adjusted  (1)
CL Item
Temporarily interrupted (2)
CL Item
Permanently discontinued  (3)
CL Item
Not applicable (X)
Item
Did subject withdraw from study as a result of non-serious AE?
text
C2349954 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal
Code List
Did subject withdraw from study as a result of non-serious AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility the non-serious AE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Relationship to investigational product(s)
Code List
Is there a reasonable possibility the non-serious AE may have been caused by the investigational product(s)?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the AE meet the definition of serious?
text
C1710056 (UMLS CUI [1])
Seriousness
Code List
Does the AE meet the definition of serious?
CL Item
Yes (Y)
CL Item
No (N)
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