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Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Day 21

- 09.10.18 - 1 Formular, 3 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Fructosamine measurement, Immunogenicity Study; Blood, Pharmacokinetic aspects; Blood
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. 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: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Day 35

- 09.10.18 - 1 Formular, 2 Itemgruppen, 8 Datenelemente, 1 Sprache
Itemgruppen: Immunogenicity Study; Blood, Pharmacokinetic aspects; Blood
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. 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: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Day -1

- 09.10.18 - 1 Formular, 16 Itemgruppen, 59 Datenelemente, 1 Sprache
Itemgruppen: 12-lead ECG, Vital Signs, Clinical Chemistry, Hematology finding, Urinalysis, Free Fatty Acids measurement, Fructosamine measurement, Urine pregnancy test, Capillary Blood Glucose measurement, Pharmacodynamics, Blood, Glucose, Glucagon, Insulin, C-Peptide, Pharmacodynamics; Blood; Glucagon-Like Peptide 1, drug biological activity, Collection of blood specimen for laboratory procedure, Pharmacokinetic aspects; Blood, Antidiabetics; Tolerability Study, Adverse event, Antidiabetics; Tolerability Study; Worksheet
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. 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: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Day 9

- 08.10.18 - 1 Formular, 13 Itemgruppen, 47 Datenelemente, 1 Sprache
Itemgruppen: 12-lead ECG, Vital Signs, Clinical Chemistry, Hematology finding, Urinalysis, Capillary Blood Glucose measurement, Pharmacodynamics, Blood, Glucose, Glucagon, Insulin, C-Peptide, Pharmacodynamics; Blood; Glucagon-Like Peptide 1, drug biological activity, Collection of blood specimen for laboratory procedure, Pharmacokinetic aspects; Blood, Antidiabetics; Tolerability Study, Adverse event, Antidiabetics; Tolerability Study; Worksheet
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. 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: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Day 9

- 08.10.18 - 1 Formular, 13 Itemgruppen, 47 Datenelemente, 1 Sprache
Itemgruppen: 12-lead ECG, Vital Signs, Clinical Chemistry, Hematology finding, Urinalysis, Capillary Blood Glucose measurement, Pharmacodynamics, Blood, Glucose, Glucagon, Insulin, C-Peptide, Pharmacodynamics; Blood; Glucagon-Like Peptide 1, drug biological activity, Collection of blood specimen for laboratory procedure, Pharmacokinetic aspects; Blood, Antidiabetics; Tolerability Study, Adverse event, Antidiabetics; Tolerability Study; Worksheet
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. 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: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Day 8

- 05.10.18 - 1 Formular, 11 Itemgruppen, 40 Datenelemente, 1 Sprache
Itemgruppen: 12-lead ECG, Electrocardiogram; Telemetry, Vital Signs, Clinical Chemistry, Hematology finding, Urinalysis, Capillary Blood Glucose measurement, drug biological activity, Collection of blood specimen for laboratory procedure, Pharmacokinetic aspects; Blood, Experimental drug, Therapeutic procedure; Confirmation
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. 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: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Pharmacokinetics Blood and Emotional Test Battery

- 21.08.18 - 1 Formular, 5 Itemgruppen, 6 Datenelemente, 1 Sprache
Itemgruppen: Pharmaceutical Preparations; Dosage; Date in time; Time, Pre-dose, Tests (qualifier value) | Series | Emotional | Before, Tests (qualifier value) | Series | Emotional | Post, Tests (qualifier value) | Series | Emotional | Date in time | Tests (qualifier value) | Series | Emotional | Time
Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram Study Indication: Depressive Disorder and Anxiety Disorders

Safety of once-daily administration of Fluticasone nasal spray in adults and adolescents with perennial allergic rhinitis GSK 102123 - Administrative Data and Pharmacokinetics and Laboratory - Visit 8

- 18.05.18 - 1 Formular, 4 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Investigational Product, Pharmacokinetics, Investigational Product Container Number, Central Laboratory
Study ID: 102123 Clinical Study ID: FFR102123 Study Title: A randomised double-blind placebo controlled parallel group multicentre long term study to evaluate the safety of once-daily, intranasal administration of GW685698X aqueous nasal spray 100mcg* for 52 weeks in adult and adolescent subjects with perennial allergic rhinitis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: FLUTIDE, Allermist, Veramyst, FLUNASE, FLIXOTAIDE, FLUTAIDE, FLIXOVATE, Avamys; Veramyst, Avamys, Allermist Study Indication: Rhinitis, Allergic, Perennial This ODM-file contains Administrative Data and Pharmacokinetics and Laboratory; Visit 8, Week 24, Day 169+/-2 days.

Safety of once-daily administration of Fluticasone nasal spray in adults and adolescents with perennial allergic rhinitis GSK 102123 - Administrative Data - Visit 11

- 18.05.18 - 1 Formular, 3 Itemgruppen, 8 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Investigational Product Container Number, Investigational Product, Pharmacokinetics
Study ID: 102123 Clinical Study ID: FFR102123 Study Title: A randomised double-blind placebo controlled parallel group multicentre long term study to evaluate the safety of once-daily, intranasal administration of GW685698X aqueous nasal spray 100mcg* for 52 weeks in adult and adolescent subjects with perennial allergic rhinitis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: FLUTIDE, Allermist, Veramyst, FLUNASE, FLIXOTAIDE, FLUTAIDE, FLIXOVATE, Avamys; Veramyst, Avamys, Allermist Study Indication: Rhinitis, Allergic, Perennial This ODM-file contains Administrative Data; Visit 11, Week 36, Day 253+/-2 days.

Safety of once-daily administration of Fluticasone nasal spray in adults and adolescents with perennial allergic rhinitis GSK 102123 - Administrative Data and Pharmacokinetics and Laboratory - Visit 15

- 18.05.18 - 1 Formular, 3 Itemgruppen, 9 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Investigational Product, Pharmacokinetics, Central Laboratory
Study ID: 102123 Clinical Study ID: FFR102123 Study Title: A randomised double-blind placebo controlled parallel group multicentre long term study to evaluate the safety of once-daily, intranasal administration of GW685698X aqueous nasal spray 100mcg* for 52 weeks in adult and adolescent subjects with perennial allergic rhinitis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: FLUTIDE, Allermist, Veramyst, FLUNASE, FLIXOTAIDE, FLUTAIDE, FLIXOVATE, Avamys; Veramyst, Avamys, Allermist Study Indication: Rhinitis, Allergic, Perennial This ODM-file contains Administrative Data and Pharmacokinetics and Laboratory; Visit 15, Week 52, Day 365+/-2 days.

Safety of once-daily administration of Fluticasone nasal spray in adults and adolescents with perennial allergic rhinitis GSK 102123 - Administrative Data and Pharmacokinetics and Laboratory - Visit 5

- 18.05.18 - 1 Formular, 4 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Investigational Product, Pharmacokinetics, Investigational Product Container Number, Central Laboratory
Study ID: 102123 Clinical Study ID: FFR102123 Study Title: A randomised double-blind placebo controlled parallel group multicentre long term study to evaluate the safety of once-daily, intranasal administration of GW685698X aqueous nasal spray 100mcg* for 52 weeks in adult and adolescent subjects with perennial allergic rhinitis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: FLUTIDE, Allermist, Veramyst, FLUNASE, FLIXOTAIDE, FLUTAIDE, FLIXOVATE, Avamys; Veramyst, Avamys, Allermist Study Indication: Rhinitis, Allergic, Perennial This ODM-file contains Administrative Data and Pharmacokinetics and Laboratory; Visit 5, Week 12, Day 85+/-2 days.

Safety of once-daily administration of Fluticasone nasal spray in adults and adolescents with perennial allergic rhinitis GSK 102123 - Administrative Data and Pharmacokinetics - Visit 3

- 18.05.18 - 1 Formular, 3 Itemgruppen, 8 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Investigational Product, Pharmacokinetics, Investigational Product Container Number
Study ID: 102123 Clinical Study ID: FFR102123 Study Title: A randomised double-blind placebo controlled parallel group multicentre long term study to evaluate the safety of once-daily, intranasal administration of GW685698X aqueous nasal spray 100mcg* for 52 weeks in adult and adolescent subjects with perennial allergic rhinitis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: FLUTIDE, Allermist, Veramyst, FLUNASE, FLIXOTAIDE, FLUTAIDE, FLIXOVATE, Avamys; Veramyst, Avamys, Allermist Study Indication: Rhinitis, Allergic, Perennial This ODM-file contains Administrative Data and Pharmacokinetics; Visit 3, Week 4, Day 29+/-2 days.

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