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GSK Study Unscheduled Visit HEMATOLOGY AND CLINICAL CHEMISTRY LOCAL NCT00079911

- 06-04-22 - 1 Formulier, 3 Itemgroepen, 30 Data-elementen, 1 Taal
Itemgroepen: Study administration, HEMATOLOGY, CLINICAL CHEMISTRY
NCT00079911 Study ID 100181 Clinical Study ID HS2100181 Study Title: An International, Randomized, Double-Blind, Placebo-Controlled Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons with CD4+ lymphocyte count 100 cells/mm3. Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00079911 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Terminated Generic Name: valaciclovir Trade Name: ZELITREX,Valtrex,RAPIVIR,Novirus Study Indication: Genital Herpes; HIV infection

GSK Study Unscheduled Visit HEMATOLOGY AND CLINICAL CHEMISTRY LOCAL NCT00079911

- 06-04-22 - 1 Formulier, 3 Itemgroepen, 30 Data-elementen, 1 Taal
Itemgroepen: Study administration, HEMATOLOGY, CLINICAL CHEMISTRY
NCT00079911 Study ID 100181 Clinical Study ID HS2100181 Study Title: An International, Randomized, Double-Blind, Placebo-Controlled Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons with CD4+ lymphocyte count 100 cells/mm3. Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00079911 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Terminated Generic Name: valaciclovir Trade Name: ZELITREX,Valtrex,RAPIVIR,Novirus Study Indication: Genital Herpes; HIV infection

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride – 106218 - Treatment Period - Day 15 - Pharmacokinetics (Blood)

- 17-01-19 - 1 Formulier, 2 Itemgroepen, 6 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Pharmacokinetic aspects; Blood
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 104056 - Visit 5

- 11-01-19 - 1 Formulier, 23 Itemgroepen, 137 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Elimination Criteria During The Study, Contraindications To Subsequent Vaccination, Absolute Contraindications for InfanrixTM-IPV and Aventis PediacelTM Combination Vaccines, Precautions for Vaccination, Informed Consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, Randomisation / Treatment Allocation, Physical Examination, Vaccine History, Laboratory Tests - Blood, Vaccine Administration, Vaccine, Vaccine 2, Non-administration, Unsolicited Adverse Events, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - Local Symptoms - Vaccine 2, Solicited Adverse Events, General Symptoms
Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Early Term Data: Vital Signs, Physical Examination, ECG, Laboratory Tests

- 28-12-18 - 1 Formulier, 9 Itemgroepen, 55 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Physical Examination, Electrocardiogram, Overall Interpretation of ECG, Hematologic Test, Chemistry Test, UA / Urine Chemistry Test
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 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

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Follow-Up: Vital Signs, Electrocardiogram, Laboratory Tests

- 28-12-18 - 1 Formulier, 9 Itemgroepen, 56 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Vital Signs - Duplicate 1, Duplicate 2, Physical Examination, Electrocardiogram, Overall Interpretation of ECG, Hematologic Test, Chemistry Test, UA / Urine Chemistry Test
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 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

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 2 Day 18 + Day 19 + Day 20

- 27-12-18 - 1 Formulier, 21 Itemgroepen, 112 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Day 18, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Day 19, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Study Drug Administration 2 , Pharmacokinetic Blood Collection, Day 20, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Electrocardiogram, Overall Interpretation of ECG, Study Drug Administration, Hematologic Test, Chemistry Test, UA/Urine Chemistry, Pharmacokinetic Blood Collection
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 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

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 1 Day 20-21 (Visit 140-150): Vital Signs, Drug Administration, ECG, Laboratory Tests

- 24-12-18 - 1 Formulier, 18 Itemgroepen, 91 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Vital Signs, Duplicate 1, Duplicate 2, Study Drug Administration, Hematology Test, Chemistry Test, UA / Urine Chemistry Test, Pharmacokinetic Blood Collection, Period 1 - Day 21, Vital Signs, Duplicate 1, Duplicate 2, Electrocardiogram, Overall Interpretation of ECG, Study Drug Administration, Pharmacodynamic Blood Connection, Pharmacokinetic Blood Collection 12 hr span
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 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

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 1 Day 14 (Visit 120): Pharmacodynamics, Vital Signs, Drug Administration

- 21-12-18 - 1 Formulier, 4 Itemgroepen, 28 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Study Drug Administration, Vital Signs, Pharmacodynamic Blood Collection
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 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

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - Unscheduled Visit: Local Laboratory Result Data: Haematology

- 19-12-18 - 1 Formulier, 2 Itemgroepen, 21 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Hematologic Tests
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - Follow-Up: Local Laboratory Result Data: Haematology

- 19-12-18 - 1 Formulier, 2 Itemgroepen, 21 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Hematologic Tests
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Immogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020 - Visit 2: Laboratory Tests

- 23-11-18 - 1 Formulier, 2 Itemgroepen, 5 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Blood Sample
Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella CRF Seiten: 268-336; 870-938

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