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34780

Description

Study ID: 101998 Clinical Study ID: 101998 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor GlaxoSmithKline Collaborators N/A Phase Phase 3 Study Recruitment Status Completed Generic Name sumatriptan Trade Name Imitrex ,Imiject ,Imigran Study Indication Migraine Disorders 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. Examples of an AE includes: • Significant or unexpected worsening or exacerbation of the condition/ indication under study. • Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition. • New condition(s) 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 subject’s condition. For GSK clinical studies, AEs may include pre- or post-treatment events that occur as a result of protocol-mandated procedures (i.e., invasive procedures, modification of subject’s previous therapeutic regimen). See protocol for clarification. IF THIS EVENT MEETS THE DEFINITION OF SERIOUS, COMPLETE THE SERIOUS ADVERSE EVENT SECTION Check that either ’Yes’ or ’No’ box at the top of the page has been completed. • Start dates must be provided for the reporting of adverse event data. If the exact date is not known, liaise with the investigator to ensure that a best estimate is provided. • Ensure that no medical or investigational procedures are captured on Non-Serious Adverse Events pages. • Non-serious adverse event terms should be reviewed for potential SAEs per protocol. • Confirm that any adverse events marked as Recovering/Resolving or Not recovered/Not resolved have been followed up for details of resolution. • If the subject was withdrawn from the study due to an adverse event, confirm that the following variables are consistent for the adverse event which resulted in withdrawal: • If investigational product was permanently withdrawn due to an adverse event ... • Primary Reason for Withdrawal’ on the Study Conclusion page is recorded as ’Adverse Event’ • If the subject was withdrawn from the study for an adverse event ... • ’Withdrawal’ on the Non-Serious Adverse Events page is recorded as ’Yes’. • ’Action Taken with Investigational Product(s) as a Result of the Non-Serious AE’ on the Non-Serious Adverse Events page is recorded as ’Investigational Product Withdrawn’.

Mots-clés

Versions (3)
  1. 24/01/2019 24/01/2019 -
  2. 26/01/2019 26/01/2019 -
  3. 28/01/2019 28/01/2019 - Sarah Riepenhausen
Détendeur de droits

GlaxoSmithKline

Téléchargé le

28 janvier 2019

DOI

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Creative Commons BY-NC 3.0
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    Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998

    Anglais

    Non-Serious Adverse Events Form

    1 Formulaires  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Identifier
    Description

    Subject Identifier

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Non-serious Adverse Event
    Description

    Non-serious Adverse Event

    Alias
    UMLS CUI-1
    C1518404 (Non-serious Adverse Event)
    Did the subject experience any non-serious adverse events during the study?
    Description

    If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form. If Yes, record details below.

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1518404 (Non-serious Adverse Event)
    Non-Serious Adverse Event
    Description

    Non-Serious Adverse Event

    Alias
    UMLS CUI-1
    C1518404 (Non-serious Adverse Event)
    Event (diagnosis only, otherwise sign/symptom)
    Description

    Enter only the diagnosis (if known); otherwise enter sign or symptom. If a diagnosis subsequently becomes available, then this should be entered and the sign or symptom crossed out, initialled and dated by the investigator.

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1518404 (Non-serious Adverse Event)
    Start Date
    Description

    Day onth Year Record the start date of the first occurrence of the AE.

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0808070 (Start Date)
    UMLS CUI [1,2]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Start Time
    Description

    Hr : Min 00:00-23:59 Record the start time of the AE.

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    UMLS CUI [1,2]
    C1518404 (Non-serious Adverse Event)
    Outcome
    Description

    All AEs must be followed until the events are resolved, the condition stabilises, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was ’Recovered/Resolved’ or ’Recovered/Resolved with sequelae’. If the AE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as ’Not recovered/Not resolved’ or ’Recovering/Resolving’. Also enter ’Not recovered/Not resolved’ if the AE was ongoing at the time of death, but was not the cause of death.

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1705586 (Adverse Event Outcome)
    End Date
    Description

    Day Month Year Record the end date. This is the date the AE Recovered/Resolved. If the event Recovered/Resolved with sequelae, enter the date the subject’s medical condition resolved or stabilised. Leave blank if the AE is ’Not recovered/Not resolved’ or ’Recovering/Resolving’.

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    UMLS CUI [1,2]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Maximum Intensity
    Description

    Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases. Mild = An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate = An event that is sufficiently discomforting to interfere with normal everyday activities. Severe = An event that prevents normal everyday activities. Not applicable = those event(s) where intensity is meaningless or impossible to determine (i.e., blindness and coma).

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0518690 (Symptom intensity)
    UMLS CUI [1,2]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
    Description

    Investigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. Dose reduced = Dose is reduced for one or more investigational product(s). Dose increased = Dose increased for one or more investigational product(s). Dose not changed = Investigational product(s) continues even though an adverse event has occured. Dose interrupted = Administration of one or more investigational product(s) was stopped temporarily but then restarted. Not applicable = Subject was not receiving investigational product(s) when the event occurred (e.g., pre- or post-dosing).

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1704758 (Action Taken with Study Treatment)
    UMLS CUI [1,2]
    C1518404 (Non-serious Adverse Event)
    Did the subject withdraw from study as a result of this AE?
    Description

    Indicate ’Yes’ if the event(s) were directly responsible for the subject’s withdrawal as indicated on the Study Conclusion page, otherwise indicate ’No’.

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C2349954 (Withdraw (activity))
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Description

    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 reasonable possibility’ is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence or arguments that may support ’a reasonable possibility’ include, e.g., a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered.

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1518404 (Non-serious Adverse Event)
    UMLS CUI [1,2]
    C0013230 (Investigational New Drugs)
    UMLS CUI [1,3]
    C0439849 (Relationships)
    SNOMED
    263498003
    LOINC
    LP146886-9
    Retour au début de la page

    Similar models

    Non-Serious Adverse Events Form

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Non-serious Adverse Event
    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)
    Item Group
    Non-Serious Adverse Event
    C1518404 (UMLS CUI-1)
    Event
    Item
    Event (diagnosis only, otherwise sign/symptom)
    text
    C1518404 (UMLS CUI [1])
    Start Date
    Item
    Start Date
    text
    C0808070 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Start Time AE
    Item
    Start Time
    time
    C1301880 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Item
    Outcome
    integer
    C1705586 (UMLS CUI [1])
    Outcome
    Code List
    Outcome
    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
    Item
    End Date
    text
    C0806020 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    Maximum Intensity
    integer
    C0518690 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Maximum Intensity
    Code List
    Maximum Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    Not applicable (4)
    Item
    Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
    integer
    C1704758 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Action Taken with Investigational Product
    Code List
    Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
    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 (6)
    Item
    Did the subject withdraw from study as a result of this AE?
    text
    C0877248 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    Withdrawal
    Code List
    Did the subject withdraw from study as a result of this AE?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    text
    C1518404 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    Relationship to investigational products
    Code List
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Retour au début de la page 

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