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ID

33028

Description

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.

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Versions (2)
  1. 11/22/18 11/22/18 -
  2. 11/23/18 11/23/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 23, 2018

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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

    English

    Non-Serious Adverse Events

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Subject Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Session Number
    Description

    Session Number

    Data type

    integer

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

    Non-Serious Adverse Events

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

    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.

    Data type

    text

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

    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.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0011900
    Date of onset
    Description

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

    Data type

    date

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

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

    Data type

    time

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

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

    Data type

    text

    Alias
    UMLS CUI [1]
    C1710066
    Outcome
    Description

    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.

    Data type

    text

    Alias
    UMLS CUI [1]
    C1705586
    Date of resolution
    Description

    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".

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985918
    Time of resolution
    Description

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

    Data type

    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
    Description

    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).

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1704758
    UMLS CUI [1,2]
    C1518404
    Did subject withdraw from study as a result of non-serious AE?
    Description

    Indicate only the event(s) directly responsible for the subject's withdrawal as indicated on the End of Study Record page.

    Data type

    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)?
    Description

    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.

    Data type

    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?
    Description

    If you tick YES, fill in the SAE form!

    Data type

    text

    Alias
    UMLS CUI [1]
    C1710056
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    Similar models

    Non-Serious Adverse Events

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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