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Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138 - Date of Visit/ Assessment, Unscheduled Assessments Performed, Vital signs, Candidiasis Examination, Electronically transferred lab data, Liver Events Assessment (Unscheduled); Date of Visit/ Assessment, Status of Treatment Blind, Pregnancy Information, Pharmacogenetic (PGx) Research Withdrawal of Consent, Study Conclusion, Investigator Signature (End of Study)

- 23/11/2018 - 1 Formulier, 12 Itemgroepen, 33 Data-elementen, 1 Taal

Itemgroepen: Date of Visit/ Assessment - Unscheduled, Unscheduled Assessments Performed, Vital signs, Candidiasis Examination , Electronically transferred lab data , Liver Events Assessment , Date of Visit/ Assessment - End of Study, Status of Treatment Blind, Pregnancy Information, Pharmacogenetic (PGx) Research Withdrawal of Consent, Study Conclusion, Investigator Siganture

Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Pregnancy Information

- 06/12/2018 - 1 Formulier, 1 Itemgroep, 2 Data-elementen, 1 Taal

Itemgroep: Pregnancy Information

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

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - End of Study - Pregnancy Information; Study Conclusion; Investigator Comment Log; Investigator's Signature

- 19/01/2021 - 1 Formulier, 5 Itemgroepen, 12 Data-elementen, 1 Taal

Itemgroepen: Administrative, Pregnancy Information, Study Conclusion, Investigator Comment Log, Investigator's Signature

Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Follow-up - Electronically Transferred Lab Data; 12-Lead ECG; Vital Signs; Study Conclusion; Pregnancy Information

- 23/04/2019 - 1 Formulier, 9 Itemgroepen, 40 Data-elementen, 1 Taal

Itemgroepen: Administrative Data, Electronically Transferred Lab Data - Pre dose, Electronically Transferred Lab Data - 24 hrs (Day 2), Electronically Transferred Lab Data - 72 hrs (Day 4) , 12-Lead ECG, Vital Signs, Study Conclusion, Pregnancy Information (F), Pregnancy Information (M)

Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026 - Study conclusion, pregnancy information

- 20/12/2018 - 1 Formulier, 3 Itemgroepen, 11 Data-elementen, 1 Taal

Itemgroepen: Administrative data, Study conclusion, Pregnancy information

Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 8 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the study conclusion form and the pregnancy information. It has to be filled in for the end of study.

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Pregnancy Information

- 05/10/2018 - 1 Formulier, 1 Itemgroep, 2 Data-elementen, 1 Taal

Itemgroep: Pregnancy; Information

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

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Pregnancy Information

- 29/11/2020 - 1 Formulier, 6 Itemgroepen, 63 Data-elementen, 1 Taal

Itemgroepen: Administrative , Demography and Medical History (Pregnancy Notification Form), Pregnancy Information (Pregnancy Notification Form) , Demography and Medical History (Pregnancy Outcome Form), Child Information (Pregnancy Outcome Form), Pregnancy Outcome Information (Pregnancy Outcome Form)

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - Pregnancy Information; Study Conclusion; Investigator Comment Log; Investigator's Signature

- 03/08/2020 - 1 Formulier, 5 Itemgroepen, 12 Data-elementen, 1 Taal

Itemgroepen: Administrative, Pregnancy Information, Study Conclusion, Investigator Comment Log, Investigator's Signature

Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Screening - Demography; Child-bearing Potential; Pregnancy Test; Physical Examination; Vital Signs; Medical Conditions

- 06/01/2021 - 1 Formulier, 8 Itemgroepen, 25 Data-elementen, 1 Taal

Itemgroepen: Administrative, Demography, Child-Bearing Potential, Pregnancy Test, Physical Examination, Vital Signs, Vital Signs , Medical Conditions

Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Death; Study Conclusion; Pharmacogenetic Research Withdrawal of Consent; Pregnancy Information; Investigatoinal Product Discontinuation; Investigational Product Compliance - Pazopanib; Log Status

- 23/05/2019 - 1 Formulier, 7 Itemgroepen, 26 Data-elementen, 1 Taal

Itemgroepen: Death, Study Conclusion, Pharmacogenetic Research Withdrawal of Consent, Pregnancy Information, Investigational Product Discontinuation, Investigational Product Compliance, Log Status

Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Follow-Up - ECG; Vital Signs; Pulmonary Function Test; Pregnancy Information; Status of treatment blind; Study conclusion

- 05/12/2020 - 1 Formulier, 9 Itemgroepen, 36 Data-elementen, 1 Taal

Itemgroepen: Date of visit/assessment, ECG, Vital Signs - Follow-up 1, Vital Signs - Follow-up 2, Vital Signs - Follow-up 3, Pulmonary Function Tests, Pregnancy Information, Status of Treatment Blind, Study Conclusion

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Pregnancy notification form (subject's partner)

- 07/12/2018 - 1 Formulier, 7 Itemgroepen, 42 Data-elementen, 1 Taal

Itemgroepen: Administrative data, Mothers relevant medical/family history, Number of previous pregnancies, Fathers relevant medical/family history, DRUG EXPOSURES, Withdraw from study, REPORTING INVESTIGATOR INFORMATION

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 Pregnancy notification form (subject's partner). Complete this form for each subject's partner who becomes pregnant during the study period. This form should be completed according to the protocol reporting requirements. Complete this form for each subject's partner who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail or fax (fax preferred) within two weeks of learning of the pregnancy. Original pages should remain with the subject's Case Report Form. Note: This form does not routinely need to be completed for subject's partner pregnancy unless there is specific instruction to do so stated in the protocol.

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