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Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Headache Classification

- 20.09.21 - 1 Formular, 4 Itemgruppen, 12 Datenelemente, 1 Sprache

Itemgruppen: Administrative Information, IHS Headache Classification, Migraine History, Subject Recruitment

https://www.gsk-clinicalstudyregister.com/study/101998#rs 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 Sponsor :GlaxoSmithKline Sponsor Identification Number :TRX101998 Collaborators :N/A Phase :Phase 3 Study Recruitment Status :Completed Generic Name :sumatriptan Trade Name :Imitrex ,Imiject ,Imigran Study Indication :Migraine Disorders This form uses the IHS headache classification to evluate the subjects symptoms of headache and migraine and should be filled out at the screening visit.

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Eligibility Criteria

- 20.09.21 - 1 Formular, 4 Itemgruppen, 41 Datenelemente, 1 Sprache

Itemgruppen: Administrative Information, Eligibility Question, Inclusion Criteria, Exclusion Criteria

https://www.gsk-clinicalstudyregister.com/study/101998#rs 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 Sponsor :GlaxoSmithKline Sponsor Identification Number :TRX101998 Collaborators :N/A Phase :Phase 3 Study Recruitment Status :Completed Generic Name :sumatriptan Trade Name :Imitrex ,Imiject ,Imigran Study Indication :Migraine Disorders This form asks for the inclusion and exclusion criteria of the study and should be filled out at the screening visit.

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Serious Adverse Event Notification Form

- 04.02.19 - 1 Formular, 15 Itemgruppen, 61 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Serious Adverse Event, SECTION 1: Serious Adverse Event Record, SECTION 2: Seriousness, SECTION 3: Demography Data, SECTION 4: Serious Adverse Event Recurrence, SECTION 5: Causes of SAE, SECTION 6: Relevant Medical Conditions, SECTION 7: Other Relevant Risk Factors, SECTION 8: Relevant Concomitant Medications, SECTION 9: Details of Investigational Product(s), SECTION 10: Details of Relevant Assessments, SECTION 11: Narrative Remarks, Conclusion, SECTION 12: Additional/Follow-Up Information

Study ID: 101198 Clinical Study ID: 101198 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 The purpose of this form is to document any serious adverse events. A serious adverse event is defined as follows: A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death. b) is life-threatening. 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. c) requires hospitalisation or prolongation of existing hospitalisation. Note: In general, hospitalisation 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 out-patient setting. Complications that occur during hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils any other serious criteria, the event is ’serious’. When in doubt as to whether ’hospitalisation’ occurred or was necessary, the AE should be considered ’serious’. Hospitalisation for elective treatment of a preexisting condition that did not worsen from baseline is not considered an AE. d) results in disability/incapacity, or 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, diarrhoea, influenza, and accidental trauma (e.g., sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption. e) is a congenital anomaly/birth defect. f) other. 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 hospitalisation but may jeopardise 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 hospitalisation, or development of drug dependency or drug abuse. • 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 serious 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 Serious Adverse Events pages. • Death should not be recorded as an SAE but should be recorded as the outcome of an SAE. The condition that resulted in the death should be recorded as the SAE. • Confirm that any SAEs 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 SAE, confirm that the following variables are consistent for the SAE 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 SAE page is recorded as ’Yes’. • ’Action Taken with Investigational Product(s) as a Result of the SAE’ on the SAE page is recorded as ’Investigational Product Withdrawn’. SECTION 4: If Investigational Product was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s)Were Administered? If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur? SECTION 9: Details of Investigational Product Complete this section using the information in the Investigational Product page. Details of all investigational product(s) taken until the time of the SAE should be included. Provide specific details in Section 11 Narrative Remarks if the subject has taken an overdose of investigational product(s), including whether it was accidental or intentional. SECTION 12: SAE Additional/Follow-up Information On receipt of follow-up information, the appropriate section(s) on the SAE form must be amended/updated with any changes (i.e., diagnosis, end date or death, change in intensity, or causality). These changes must be initialled and dated with confirmation by the investigator with his/her re-signing the form and forwarded to GSK within 24 hours. The investigator and others responsible for subject care should institute any supplementary investigations of SAEs based on their clinical judgement of the likely causative factors. This may include seeking a further opinion from a specialist in the field of the AE. GSK may also request extra tests or extra follow-up information. If a subject dies, any post-mortem/autopsy findings, including histopathology, must be provided to GSK.

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Study Conclusion

- 01.02.19 - 1 Formular, 4 Itemgruppen, 10 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Study Conclusion, Investigator Comment Log, Signature

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 This form contains the conclusion of the study, it should be filled out at the final visit.

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Pregnancy Information

- 01.02.19 - 1 Formular, 2 Itemgruppen, 3 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Pregnancy Information

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 The purpose of this form is to document if the subject became pregnant during the study.

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Non-Serious Adverse Events Form

- 28.01.19 - 1 Formular, 3 Itemgruppen, 11 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Non-serious Adverse Event, Non-Serious Adverse Event

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’.

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Study Participation Status

- 26.01.19 - 1 Formular, 6 Itemgruppen, 11 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Randomisation Number, Investigational Product Container Number, Previous Clinical Trial Participation (Migraine Treatment), PRIOR PARTICIPATION IN SUMATRIPTAN 85MG / NAPROXEN SODIUM 500MG TABLET STUDIES, Previous Administrative Data

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 The purpose of this form is to document the subjects study participation status. It should be filled out at the screening visit.

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Concomitant Medication

- 24.01.19 - 1 Formular, 3 Itemgruppen, 8 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Concomitant Medication, Concomitant Medication Record

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 The purpose of this form is to document the subjects concomitant medication. Check that either ’Yes’ or ’No’ box at the top of the page has been completed. • Ensure that the spelling of the Drug Name(s) is correct (use of Trade Names is preferred). • Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. • It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. • It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit. • Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. • It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’. • Ensure that the ’Reason for Medication’ is recorded on one of the following pages using the same terms: • Medical Conditions • Non-Serious Adverse Events • Serious Adverse Events Form

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Previous Migraine Treatment

- 17.01.19 - 1 Formular, 3 Itemgruppen, 6 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Previous Migraine Treatment, Best Medication Response

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 The purpose of this form is to record any previous treatment for migraine, the subject has taken. It should be filled out at the screening visit.

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Medical Conditions

- 17.01.19 - 1 Formular, 2 Itemgruppen, 4 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Medical Conditions

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 The purpose of this form is to document the current medical condition of the subject. It should be filled out at the screening visit.

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Investigational Product Use/Status of Treatment Blind

- 25.01.19 - 1 Formular, 3 Itemgruppen, 7 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Investigational Product Use, Status Of Treatment Blind

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 The purpose of this form is to document the subjects intake of the investigational product and the status of treatment blind. It should be filled out at the final visit.

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Child Bearing Potential and Birth Control

- 17.01.19 - 1 Formular, 3 Itemgruppen, 12 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Child-Bearing Potential, Birth Control Methods

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 This document asks if the subject is of child-bearing potential and which birth control methods the subject is using to prevent pregnancy during the study. This form should be filled out for female subjects at the screening visit.

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