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  1. 1. Clinical Trial
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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Pharmacogenetic Research Consent

- 12/4/18 - 1 form, 2 itemgroups, 7 items, 1 language
Itemgroups: Pharmacogenetic (PGx) Research Consent/ Sample Collection, Sample Type
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021 - Visit 3: Study Continuation Check

- 11/30/18 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Administrative data, Check for Study Continuation
Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021 - Visit 2: Study Continuation Check

- 11/30/18 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Administrative data, Check for Study Continuation
Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021 - Visit 1: Consent Form

- 11/28/18 - 1 form, 2 itemgroups, 3 items, 1 language
Itemgroups: Administrative data, Informed Consent
Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

Immogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020 - Consent Form

- 11/22/18 - 1 form, 2 itemgroups, 5 items, 1 language
Itemgroups: Administrative data, Informed Consent
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

Estimation of Dose Proportionality of Darapladib - 107038 - PGx-Pharmacogenetic Research Withdrawal of Consent

- 11/13/18 - 1 form, 1 itemgroup, 4 items, 1 language
Itemgroup: PGx-Pharmacogenetic Research Withdrawal of Consent
Study ID: 107038 Clinical Study ID: LPL107038 Study Title: Study to Estimate the Dose Proportionality of the Enteric-Coated Freebase Formulation of SB-480848 Patient Level Data:  Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: Tyrisa ,US Study Indication: Atherosclerosis

Estimation of Dose Proportionality of Darapladib - 107038 - PGx-Pharmacogenetic Research Consent

- 11/13/18 - 1 form, 1 itemgroup, 6 items, 1 language
Itemgroup: PGx-Pharmacogenetic Research Consent Question
Study ID: 107038 Clinical Study ID: LPL107038 Study Title: Study to Estimate the Dose Proportionality of the Enteric-Coated Freebase Formulation of SB-480848 Patient Level Data:  Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: Tyrisa ,US Study Indication: Atherosclerosis

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - Part 2: Repeat Dose Phase - Day 21 - Treatment confirmation

- 10/24/18 - 1 form, 3 itemgroups, 7 items, 1 language
Itemgroups: Administrative data, Investigational Product, Treatment Confirmation
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 - Part 2: Repeat Dose Phase - Day 21 - Treatment confirmation

- 10/24/18 - 1 form, 3 itemgroups, 7 items, 1 language
Itemgroups: Administrative data, Investigational Product, Treatment Confirmation
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

Updated informed consent GSK study Chronic Coronary Heart Disease NCT00799903

- 1/11/18 - 1 form, 1 itemgroup, 6 items, 1 language
Itemgroup: Updated informed consent
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Updated informed consent

Pharmacogenetic research Withdrawal of consent GSK study Chronic Coronary Heart Disease NCT00799903 - Pharmacogenetic research Withdrawal of consent Subject Identification GSK study Chronic Coronary Heart Disease NCT00799903

- 1/11/18 - 1 form, 1 itemgroup, 5 items, 1 language
Itemgroup: Withdrawal of consent for PGx (DNA) / Blood sample destruction
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Pharmacogenetic research Withdrawal of consent

Screening Informed consent GOAL Trial B-cell Lymphoma NCT02499003

- 12/31/17 - 1 form, 1 itemgroup, 6 items, 1 language
Itemgroup: Informed consent
NCT02499003 The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma. Study part: Informed consent (Screening) Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

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