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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
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  6. 6. Patient-Reported Outcome
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GSK Study Unscheduled Visit HEMATOLOGY AND CLINICAL CHEMISTRY LOCAL NCT00079911

- 4/6/22 - 1 form, 3 itemgroups, 30 items, 1 language
Itemgroups: 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

- 4/6/22 - 1 form, 3 itemgroups, 30 items, 1 language
Itemgroups: 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)

- 1/17/19 - 1 form, 2 itemgroups, 6 items, 1 language
Itemgroups: 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

- 1/11/19 - 1 form, 23 itemgroups, 137 items, 1 language
Itemgroups: 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

- 12/28/18 - 1 form, 9 itemgroups, 55 items, 1 language
Itemgroups: 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

- 12/28/18 - 1 form, 9 itemgroups, 56 items, 1 language
Itemgroups: 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

- 12/27/18 - 1 form, 21 itemgroups, 112 items, 1 language
Itemgroups: 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

- 12/24/18 - 1 form, 18 itemgroups, 91 items, 1 language
Itemgroups: 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

- 12/21/18 - 1 form, 4 itemgroups, 28 items, 1 language
Itemgroups: 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

- 12/19/18 - 1 form, 2 itemgroups, 21 items, 1 language
Itemgroups: 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

- 12/19/18 - 1 form, 2 itemgroups, 21 items, 1 language
Itemgroups: 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

- 11/23/18 - 1 form, 2 itemgroups, 5 items, 1 language
Itemgroups: 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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