ID

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’.

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1. 1/24/19 1/24/19 -
2. 1/26/19 1/26/19 -
3. 1/28/19 1/28/19 - Sarah Riepenhausen

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GlaxoSmithKline

Uploaded on

January 28, 2019

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