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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Pharmacogenetik Research Consent Withdrawal

- 06-12-18 - 1 Formulier, 1 Itemgroep, 6 Data-elementen, 1 Taal

Itemgroep: Withdrawal of concent for PGx/Sample Destruction

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

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

- 04-12-18 - 1 Formulier, 2 Itemgroepen, 7 Data-elementen, 1 Taal

Itemgroepen: 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

10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010 - Use of Human Samples

- 03-09-19 - 1 Formulier, 3 Itemgroepen, 12 Data-elementen, 1 Taal

Itemgroepen: Administrative documentation, Use of human samples by Sponsor, Investigator's signature

Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. In addition to the use of samples for the tests described in the protocol, the sponsor might use samples for additional research; therefore, this form records what is also covered by the subject Informed Consent form of each center.

Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652 - Lab Reference Ranges, Consent Form

- 07-03-19 - 1 Formulier, 6 Itemgroepen, 89 Data-elementen, 1 Taal

Itemgroepen: Administrative data, LABORATORY REFERENCE RANGES, Hematology, Blood Chemistry, USE OF HUMAN SAMPLES BY GSK, INVESTIGATOR'S SIGNATURE

Study ID: 111652 Clinical Study ID: 111652 Study Title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00756067 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK2189241A Trade Name: Pneumo 23™ Study Indication: Infections, Streptococcal

Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Investigational product, treatment confirmation

- 10-12-18 - 1 Formulier, 3 Itemgroepen, 6 Data-elementen, 1 Taal

Itemgroepen: Administrative data, Investigational product, Treatment confirmation

Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the investigational product and treatment confirmation form. It has to be filled in for study visit.

Updated informed consent GSK study Chronic Coronary Heart Disease NCT00799903

- 11-01-18 - 1 Formulier, 1 Itemgroep, 6 Data-elementen, 1 Taal

Itemgroep: 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

- 11-01-18 - 1 Formulier, 1 Itemgroep, 5 Data-elementen, 1 Taal

Itemgroep: 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

Investigators signature Mepolizumab HES NCT00086658 - Investigators signature

- 05-06-17 - 1 Formulier, 1 Itemgroep, 5 Data-elementen, 1 Taal

Itemgroep: Investigators signature

Study part: Investigators signature.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

WTZ-GIST-09-01 (Imatinib + LBH589) Informed Consent 2009-011417-24 DRKS00000657 - WTZ-GIST-09-01 (Imatinib + LBH589) Informed Consent 2009-011417-24

- 23-11-16 - 1 Formulier, 1 Itemgroep, 3 Data-elementen, 1 Taal

Itemgroep: Informed Consent

Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).

Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065 - Visit 1: Consent Form

- 05-12-18 - 1 Formulier, 2 Itemgroepen, 3 Data-elementen, 1 Taal

Itemgroepen: Administrative data, Informed Consent

Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Consent on genetic diagnostics Pediatric Hematology and Oncology UK Muenster

- 16-11-16 - 1 Formulier, 1 Itemgroep, 15 Data-elementen, 2 Talen

Itemgroep: Informed Consent

Freigabe zur Verarbeitung durch Frau Prof. Rössig, Quellenangabe: "Pädiatrische Hämatologie und Onkologie, UKM" Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Münster Released for adaption by Frau Prof. Rössig Source:Pediatric Hematology und Oncology, University hospital Münster

Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532) - Baseline - Consent; Central Laboratory; Diary; ECG

- 09-01-20 - 1 Formulier, 11 Itemgroepen, 56 Data-elementen, 1 Taal

Itemgroepen: Administrative, Randomisation, Electronically Transferred Lab Data, Possible Liver Events, Diary - Target Day 1, Diary - Target Day 2, Diary Day 2, Target Day 3, Diary Day 3, 12 Lead Electrocardiogram , ECG Information

Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

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