Search results - Portal of Medical Data Models (MDM-Portal)

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Running Logs and End of Study - Non-Serious Adverse Events; Serious Adverse Event

- 1/19/21 - 1 form, 18 itemgroups, 59 items, 1 language

Itemgroups: Administrative, Non-Serious Adverse Events, Non-Serious Adverse Events , Serious Adverse Event, Serious Adverse Event - Section 1, Serious Adverse Event - Section 1 , Serious Adverse Event - Section 2 (Seriousness), Serious Adverse Event - Section 3 (Demography Data), Serious Adverse Event - Section 4, Serious Adverse Event - Section 5, Serious Adverse Event - Section 6 (Relevant Medical Conditions), Serious Adverse Event - Section 7, Serious Adverse Event - Section 8 (Concomitant Medication), Serious Adverse Event - Section 9 (Details of Investigational Product(s)), Serious Adverse Event - Section 9 (Details of Investigational Product(s)) , Serious Adverse Event - Section 10, Serious Adverse Event - Section 11, 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

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Screening - Serious Adverse Event; Local Laboratory; Urinalysis; Serology - Screen for HIV Antibody and Hepatitis B & C

- 1/12/21 - 1 form, 19 itemgroups, 32 items, 1 language

Itemgroups: Administrative, Serious Adverse Event, Local Laboratory - Clinical Chemistry, Local Laboratory - Clinical Chemistry , Local Laboratory - Haematology, Local Laboratory - Haematology , Urinalysis - Local, Urinalysis - Local , Urinalysis - Microscopy, Urinalysis - Microscopy , Local Laboratory - Unscheduled Clinical Chemistry, Local Laboratory - Unscheduled Clinical Chemistry , Local Laboratory - Unscheduled Haematology, Local Laboratory - Unscheduled Haematology , Unscheduled Urinalysis - Local, Unscheduled Urinalysis - Local, Urinalysis - Microscopy (Unscheduled), Urinalysis - Microscopy (Unscheduled) , Serology - Screen for HIV Antibody and Hepatitis B&C

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

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Logs and Repeats - Adverse Event/ Concomitant Medication/ Repeat Assessment Check Question; Non-Serious Adverse Events; Serious Adverse Events

- 12/7/20 - 1 form, 13 itemgroups, 92 items, 1 language

Itemgroups: Date of Visit/ Assessment, Adverse Event/ Concomitant Medication/ Repeat Assessment Check Questions, Non-Serious Adverse Event, Serious Adverse Event - Type of Report, Serious Adverse Event - Randomisation, Serious Adverse Event, Serious Adverse Event - Seriousness, Serious Adverse Event - Relevant Concomitant/ Treatment Medications, Serious Adverse Events - Relevant Medical Conditions/ Risk Factors, Serious Adverse Event - Relevant Diagnostic Results, Serious Adverse Event - Investigational Product, General Narrative Comments, Serious Adverse Event - Non clinical

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, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - Non-serious Adverse Events (AE); Serious Adverse Events (SAE)

- 7/29/20 - 1 form, 16 itemgroups, 59 items, 1 language

Itemgroups: Administrative, Non-serious Adverse Events (AE), Non-serious Adverse Events (AE) , Serious Adverse Event (SAE), Serious Adverse Event (SAE) - Section 1, Serious Adverse Event (SAE) - Section 2 Seriousness, Serious Adverse Event (SAE) - Section 3 Demography Data, Serious Adverse Event (SAE) - Section 4, Serious Adverse Event (SAE) - Section 5 , Serious Adverse Event (SAE) - Section 6 Relevant Medical Conditions, Serious Adverse Event (SAE) - Section 7 Other relevant risk factors, Serious Adverse Event (SAE) - Section 8 Concomitant medications , Serious Adverse Event (SAE) - Section 9 Details of investigational product(s), Serious Adverse Event (SAE) - Section 10, Serious Adverse Event (SAE) - Section 11 Narrative remarks, 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)

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Non-Serious Adverse Event; Serious Adverse Events; Concomitant Medications

- 10/30/19 - 1 form, 15 itemgroups, 105 items, 1 language

Itemgroups: Non-Serious Adverse Event, Serious Adverse Event, SAE - Type of Report, SAE- Randomisation, SAE - Seriousness, SAE - Relevant Concomitant Medications, SAE - Relevant Medical Conditions/ Risk Factors, SAE - Relevant Diagnostic Results, SAE - Rechallenge, SAE - Investigational Product, SAE - Investigational Product, SAE - Investigational Product , SAE - General Narrative Comments, SAE - Non clinical, Concomitant Medications

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

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Liver Events; Investigational Product (Liver); Alcohol Intake (Liver Alcohol); Medical Conditions; Pharmacokinetics (Liver); Liver Biopsy; Liver Imaging

- 8/2/19 - 1 form, 10 itemgroups, 102 items, 1 language

Itemgroups: Liver Events, Investigational Product (Liver) , Alcohol intake, Medical Conditions (Liver), Drug related liver disease conditions, Other liver disease conditions, Other medical conditions, Pharmacokinetics (Liver PK), Liver Biopsy, Liver imaging

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

Effect of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on Annual Rate of Exacerbations in Subjects with COPD 102970 - LOGS

- 5/28/19 - 1 form, 16 itemgroups, 166 items, 1 language

Itemgroups: Administrative documentation, Non-serious Adverse Event, Serious Adverse Event, COPD exacerbation, Concomitant Agent, Date of visit, Assessment Date, Fracture, Pharmacogenetics, Informed Consent; Sampling, Experimental drug, Compliance behavior, Experimental drug, Compliance behavior, Investigational Medicinal Product Documentation, Device Malfunction, Plain chest X-ray, Pneumonia, Evaluation, Event Log, Status, Serious Adverse Event, Status, Study Subject Participation Status

Study ID: 102970 Clinical Study ID: 102970 Study Title: A 52-week Efficacy and Safety Study to Compare the Effect of Three Dosage Strengths of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on the Annual Rate of Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01017952 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: GW642444 Inhalation Powder; FF/GW642444 Inhalation Powder Trade Name: Fluticasone Furoate;Fluticasone Propionate;Fluticasone Propionate/Salmeterol;Salmeterol;Vilanterol Study Indication: Pulmonary Disease, Chronic Obstructive

Effect of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on Annual Rate of Exacerbations in Subjects with COPD; 102970 - LE Details

- 2/25/19 - 1 form, 8 itemgroups, 75 items, 1 language

Itemgroups: Administrative documentation, Date of visit, Assessment Date, Pharmacokinetic aspects, Liver, Adverse Event, Disease, Alcohol consumption; Liver; Adverse event; Onset of, Imaging of liver, Biopsy of liver

Study ID: 102970 Clinical Study ID: 102970 Study Title: A 52-week Efficacy and Safety Study to Compare the Effect of Three Dosage Strengths of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on the Annual Rate of Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01017952 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: GW642444 Inhalation Powder; FF/GW642444 Inhalation Powder Trade Name: Fluticasone Furoate;Fluticasone Propionate;Fluticasone Propionate/Salmeterol;Salmeterol;Vilanterol Study Indication: Pulmonary Disease, Chronic Obstructive

Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181 - Serious Adverse Events

- 12/10/18 - 1 form, 12 itemgroups, 39 items, 1 language

Itemgroups: Serious Adverse Event, Serious Adverse Event, Seriousness of Adverse Event, Serious Adverse Event, Demographics Domain, Serious Adverse Event, Experimental drug, Serious Adverse Event, Causations, Serious Adverse Event, Disease, Serious Adverse Event, Risk Factors, Serious Adverse Event, Concomitant Agent, Serious Adverse Event, Experimental Drug, Details, Serious Adverse Event, Evaluation, Details, Serious Adverse Event, Comment, Serious Adverse Event, Investigator Signature, Investigator Name

Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive

Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181 - Non-Serious Adverse Events

- 12/5/18 - 1 form, 1 itemgroup, 12 items, 1 language

Itemgroup: Non-Serious Adverse Events

Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive

Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138 - SAE Status, Log Status, Subject Withdrawal Status, Serious Adverse Events, Non- Serious Adverse Event - Subjects Logs

- 11/16/18 - 1 form, 14 itemgroups, 82 items, 1 language

Itemgroups: SAE Log Status, Log Status, Subject Withdrawal Status, Serious Adverse Event, Serious Adverse Event- Randomisation, Serious Adverse Event, Serious Adverse Event - Seriousness, Serious Adverse Event - Relevant Concomitant/ Treatment Medications, Serious Adverse Event - Relevant Conditions/ Risk Factors, Serious Adverse Event - Relevant Diagnostic Results, Serious Adverse Event - Rechallenge, Serious Adverse Event - Investigational Product, Serious Adverse Event - General Narrative Comments, Non- serious Adverse Event

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

Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125 - Logs/ Repeats, Non- Serious Adverse Event, Serious Adverse Event, Concomitant Medication, Electronically Transferred Lab Data, Vital Signs, ECG, Repeat Pharmacodynamics - Cortisol, Glucose, Potassium, FF/GWG642444M, Defective Inhaler, X Ray Pneumonia Confirmation

- 10/27/18 - 1 form, 20 itemgroups, 128 items, 1 language

Itemgroups: Date of Visit/ Assessment, Adverse Event/ Concomitant Medication/ Repeat Assessment Check Questions, Non- serious Adverse Event, Serious Adverse Event, Relevant medical conditions/ risk factors, Relevant Concomitant/ Treatment Medications, Relevant Diagnostic Results, Investigational Product, General Narrative Comments, Concomitant Medication, Electronically transferred lab data, Vital signs , 12- Lead ECG, ECG Abnormalities, Pharmacodynamics - Cortisol , Pharmacodynamics Results - Glucose, Pharmacodynamics Results - Potassium, Pharmacokinetics Blood - FF/GW642444M , Defective Inhaler, X Ray Pneumonia Confirmation

Study ID: 105548 Clinical Study ID: HZA105548 Study Title: A double-blind, randomized, placebo-controlled, repeat dose, 2-way crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects following administration of fluticasone furoate/GW642444M Inhalation Powder with ketoconazole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165125 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol; vilanterol Trade Name: Relvar; vilanterol Study Indication: Asthma

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