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

- 25/01/2019 - 1 Formulaire, 3 Groupes Item, 7 Eléments de données, 1 Langue
Groupes Item: 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 - Concomitant Medication

- 24/01/2019 - 1 Formulaire, 3 Groupes Item, 8 Eléments de données, 1 Langue
Groupes Item: 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 - Child Bearing Potential and Birth Control

- 17/01/2019 - 1 Formulaire, 3 Groupes Item, 12 Eléments de données, 1 Langue
Groupes Item: 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.

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

- 17/01/2019 - 1 Formulaire, 3 Groupes Item, 14 Eléments de données, 1 Langue
Groupes Item: Administrative Data, Demography, Race
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 demographic data. 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

- 17/01/2019 - 1 Formulaire, 2 Groupes Item, 4 Eléments de données, 1 Langue
Groupes Item: 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 - Previous Migraine Treatment

- 17/01/2019 - 1 Formulaire, 3 Groupes Item, 6 Eléments de données, 1 Langue
Groupes Item: 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™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Subject Diary

- 15/01/2019 - 1 Formulaire, 12 Groupes Item, 40 Eléments de données, 1 Langue
Groupes Item: Administrative Data, Migraine Symptoms, Date and Time Study Medication Taken, Details of Migraine Headache Pain and Symptoms, ALLODYNIA QUESTIONNAIRE (Complete at time of dosing), Details of Work Ability, ALLODYNIA QUESTIONNAIRE (Complete 2 hours after dosing), Recurrence, Medications Taken, Productivity, Productivity: Affect of Migraine Attack on work and non-work related activities, PATIENT PERCEPTION OF MIGRAINE QUESTIONNAIRE - REVISED (PPMQ-R)
This ODM file contains the form for the subject diary. To be filled out throughout the study. Study ID: 101999 Clinical Study ID: 101999 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 Subject Diary Instructions: Important Reminders: • All Pages: It is very important that you complete the diary information as accurately as possible and in a timely manner. Page 1: • Do NOT treat any headache with study medication until study personnel call you about your lab and ECG results. • Enter the date and time your migraine headache pain started and the date and time you took study medication. • Take the study medication ONLY within one hour of the start of migraine head pain and ONLY if your headache pain is still MILD. • If you wake up with mild migraine headache pain, you should take the study medication as soon as possible after awakening. • If you wake up with moderate or severe headache pain, you should NOT take the study medication to treat the headache. You should not use the study medication to treat your migraine headache if you have used: • nonsteroidal anti-inflammatory drugs such as ibuprofen (Advil or Motrin), naproxen (Aleve), aspirin (exception is aspirin not exceeding 325mg if taken for cardiovascular health) within 24 hours before taking study medication • an ergotamine-containing or ergot-type medication like dihydroergotamine or methysergide within 24 hours before taking study medication • a triptan (such as Imitrex, Zomig, Maxalt, Relpax, Amerge, Axert, or Frova) within 24 hours before taking study medication • medications for nausea or vomiting, narcotics, or other headache medications within 24 hours before taking study medication • any other pain medications (such as Tylenol or acetaminophen) within 6 hours before taking study medication Page 2: Complete this page at time of dosing with study medication and 30 minutes, 1 hour, 2 hours, and 4 hours after taking study medication. Page 3: Complete this page at time of dosing with study medication. Page 4: Complete this page at time of dosing with study medication and at 2 and 4 hours after dosing with study medication. Page 5: Complete this page at 2 hours after dosing with study medication. Page 6: Complete this page at 24 hours after taking study medication. Page 7: Complete this page. You should not use a medication for pain, nausea, or vomiting within 2 hours after taking study medication. If you have migraine pain from 2 to 24 hours after taking the study medication, you may take other headache medication that the study doctor has told you is acceptable to use. These include Tylenol (acetaminophen), drugs for nausea or vomiting, and narcotics. Pages 8, 9 - 12: Complete these pages 24 hours after taking study medication. • Contact the investigator if you feel any unusual symptoms after taking the study medication. • Ask the investigator if you are unsure of the above instructions. GENERAL INSTRUCTIONS FOR DIARY COMPLETION • Use black ink and print neatly and legibly. • If you make a mistake, draw a single line through the incorrect entry. • Do not 'write over' or erase an incorrect entry, or re-copy the original page. • Do not use correction materials (such as correction fluid or tape) on this diary card. DATE • Record dates in DD MMM YY format (for example: 15 JAN 04). • Use the first three letters of each month as the abbreviation for the months (e.g., JAN, FEB, MAR). TIME • Record time in 24-hour clock format unless specified otherwise, per conversion chart below. a.m. Midnight = 00:00 1:00 = 01:00 2:00 = 02:00 3:00 = 03:00 4:00 = 04:00 5:00 = 05:00 6:00 = 06:00 7:00 = 07:00 8:00 = 08:00 9:00 = 09:00 10:00 = 10:00 11:00 = 11:00 p.m. Noon = 12:00 1:00 = 13:00 2:00 = 14:00 3:00 = 15:00 4:00 = 16:00 5:00 = 17:00 6:00 = 18:00 7:00 = 19:00 8:00 = 20:00 9:00 = 21:00 10:00 = 22:00 11:00 = 23:00 Note: Midnight = 00:00 is the start of the new day, not the end of the previous day. Page 1: Migraine Symptoms - Date and Time Study Medication Taken Page 2: Details of Migraine Headache Pain and Symptoms Page 3: Allodynia Questionnaire (Complete at time of dosing) Page 4: Details of WOrk Ability Page 5: Allodynia Questionnaire (Complete 2 hours after dosing) Page 6: Recurrence Page 7: Medications Taken Page 8: Productivity Page 9: PPMQ-R Reminder to Site Personnel: Upon return of the completed diary, review the diary with the subject and address discrepancies while the subject is in the clinic. Subject Reminder: Take the study medication ONLY within one hour of the start of migraine head pain and ONLY if your headache pain is still MILD.

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Serious Adverse Event

- 09/11/2018 - 1 Formulaire, 14 Groupes Item, 56 Eléments de données, 1 Langue
Groupes Item: Administrative Data, Serious Adverse Event, SECTION 1, SECTION 2: Seriousness, SECTION 3 Demography Data, SECTION 4 If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?, SECTION 5 Possible Causes of SAE Other Than Investigational Product(s), 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, Investigator's name and signature
This ODM file contains the form to document all serious events that are temporally associated with the use of the study medication. Study ID: 101999 Clinical Study ID: 101999 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

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Childbearing Potential, Birth Control Methods and Medical Conditions

- 09/11/2018 - 1 Formulaire, 4 Groupes Item, 29 Eléments de données, 1 Langue
Groupes Item: Administrative Data, Child-bearing Potential (Complete for Female Subjects Only), Birth Control Methods, Medical Conditions
This ODM-file contains the form to document the childbearing potential, birth control methods and medical conditions of the subject. To be assessed at screening. Study ID: 101999 Clinical Study ID: 101999 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

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Demography

- 09/11/2018 - 1 Formulaire, 2 Groupes Item, 14 Eléments de données, 1 Langue
Groupes Item: Administrative Data, Demography
This ODM-file contains the form to document the demography of the subject. To be assessed at screening. Study ID: 101999 Clinical Study ID: 101999 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

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Investigatioinal Product Use and Status of Treatment Blind

- 02/11/2018 - 1 Formulaire, 3 Groupes Item, 7 Eléments de données, 1 Langue
Groupes Item: Administrative Data, Investigational Product Use, Status of Treatment Blind
This ODM-file contains the form to document the investigational product use and the status of treatment blind. To be assessed at the final visit. Study ID: 101999 Clinical Study ID: 101999 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

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Subject Recruitment, Randomisation Number, Investigational Product Container Number, Previous Clinical Trial Participation, Prior participation in Sumatriptan 85mg/Naproxen Sodium 500mg Tablet Studies

- 31/10/2018 - 1 Formulaire, 6 Groupes Item, 13 Eléments de données, 1 Langue
Groupes Item: Administrative Data, Subject Recruitment, Randomisation Number, Investigational Product Container Number, Previous Clinical Trial Participation (Migraine Treatment), Prior Participation in Sumatriptan 85mg / Naproxen Sodium 500mg Tablet Studies
This ODM-file contains the form to document the Randomisation number, the investigational product container number, the previous clinical trial participation, the subject recruitment and the prior participation in sumatriptan 85mg/ naproxen sodium 500mg tablet studies. To be assessed at screening. Study ID: 101999 Clinical Study ID: 101999 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

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