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

- 09/11/18 - 1 modulo, 4 itemgroups, 29 elementi, 1 linguaggio

Itemgroups: 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

- 09/11/18 - 1 modulo, 2 itemgroups, 14 elementi, 1 linguaggio

Itemgroups: 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

- 02/11/18 - 1 modulo, 3 itemgroups, 7 elementi, 1 linguaggio

Itemgroups: 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

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396 - Study Conclusion, Pregnancy Information, Investigator Comment Log and Investigator's Signature

- 31/10/18 - 1 modulo, 5 itemgroups, 13 elementi, 1 linguaggio

Itemgroups: Administrative Data, Pregnancy Information, Study Conclusion, Investigator Comment Log, Investigator's Signature

This ODM file contains the form to document pregnancy information at the end of the study, the study conclusion and also includes an investigator's comment log as well as the investigator's signature. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

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

- 31/10/18 - 1 modulo, 6 itemgroups, 13 elementi, 1 linguaggio

Itemgroups: 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

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

- 30/10/18 - 1 modulo, 3 itemgroups, 11 elementi, 1 linguaggio

Itemgroups: Administrative Data, Experience of a Non-Serious Adverse Event, Non-Serious Adverse Events Details

This ODM file contains the form to document all non-serious adverse 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 - Concomitant Medication

- 30/10/18 - 1 modulo, 3 itemgroups, 8 elementi, 1 linguaggio

Itemgroups: Administrative Data, Concomitant Medication, List of Concomitant Medication

This ODM file contains the form for documentation of any concomitant medication. To be assessed at screening and re-assessed at every 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

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396 - Concomitant Medication

- 28/10/18 - 1 modulo, 3 itemgroups, 13 elementi, 1 linguaggio

Itemgroups: Administrative Data, Concomitant Medication, List of Concomitant Medication

This ODM file contains the form for documentation of any concomitant medication. To be assessed at screening and re-assessed at every visit. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396 - Non-Serious Adverse Event

- 28/10/18 - 1 modulo, 3 itemgroups, 13 elementi, 1 linguaggio

Itemgroups: Administrative Data, Experience of a Non-Serious Adverse Event, Non-Serious Adverse Events Details

This ODM file contains the form to document all non-serious events that are temporally associated with the use of the study medication. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396 - Serious Adverse Event

- 28/10/18 - 1 modulo, 14 itemgroups, 59 elementi, 1 linguaggio

Itemgroups: 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: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396 - Pharmacokinetics

- 17/10/18 - 1 modulo, 2 itemgroups, 8 elementi, 1 linguaggio

Itemgroups: Administrative Data, Pharmacokinetics - Blood

This ODM file contains the form to record the pharmacokinetics. To be assessed at Day 1 of Period 1 and 2. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396 - Vital Signs, 12-Lead ECG, Laboratory Tests and Pregnancy Test (Follow-up Visit)

- 15/10/18 - 1 modulo, 5 itemgroups, 14 elementi, 1 linguaggio

Itemgroups: Administrative Data, Vital Signs, 12-Lead ECG, Laboratory Tests - Clinical Chemistry, Haematology, Pregnancy Test (Complete for Female Subjects Only)

This ODM file contains the form for documentation of the vital signs, the 12-lead ecg, the laboratory testing and the pregnancy test. To be assessed at follow-up visit. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

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