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

Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682) - Serious Adverse Event (SAE)

- 1/17/19 - 1 form, 15 itemgroups, 64 items, 1 language

Itemgroups: Administrative data, Serious Adverse Events, Demography, Serious adverse events, Possible Causes of SAE other than lnvestigational Product(s), Seriousness of SAE, Relevant Medical Conditions, Other relevant risk factors, Details of lnvestigational Product(s), Relevant Concomitant Medications, Narrative / Comments, Details of relevant Assessments, Reporting lnvestigator, Additional or follow-up information, Reporting lnvestigator

Study ID: 101682 Clinical Study ID: B2E101682 Study Title: A randomised, double-blind, placebo-controlled, parallel group study to examine the safety, tolerability, and pharmacokinetics of repeat inhaled doses of GSK159797 in healthy subjects. Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: milveterol Study Indication: Pulmonary Disease, Chronic Obstructive. This form contains information about serious adverse events and should be completed only in case of occurrence of serious adverse events.

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)

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Liver Event - Liver Events; Investigational Product; Pharmacokinetics; Medical Conditions; Alcohol Intake; Liver Imaging; Liver Biopsy

- 5/8/19 - 1 form, 13 itemgroups, 104 items, 1 language

Itemgroups: Date of Visit, Liver Event Assessment, Liver Events, Investigational Product (Liver) - during treatment period, Investigational Product (Liver) - after treatment period , Pharmacokinetics (Liver PK), Medical Conditions (Liver), Drug related liver disease conditions, Other liver disease conditions, Other medical conditions, Alcohol intake, Liver imaging, Liver Biopsy

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

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

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Logs/ Repeats - Logs and Repeats; Non- Serious Adverse Events; Serious Adverse Events; Concomitant Medication; Electronically Transferred Lab Data; Vital Signs; 12-Lead ECG; ECG Abnormalities; Repeat- Pharmacokinetics Blood - GW856553

- 5/1/19 - 1 form, 16 itemgroups, 137 items, 1 language

Itemgroups: Logs ad Repeats, Logs and Repeats - Adverse event/ Concomitant Medication/ Repeat Assessment Check Questions, Non-serious Adverse Event (AE), Serious Adverse Events (SAE), Serious Adverse Event - Concomitant Medication, Serious Adverse Event - Medical Conditions/ Risk Factors, Serious Adverse Events - Relevant diagnostic results, Serious Adverse Events - Investigational Products, Serious Adverse Events - General narrative comments, Serious Adverse Events - Non clinical, Concomitant Medication, Electronically Transferred Lab Data, Vital signs, 12-Lead ECG, ECG Abnormalities, Repeat Pharmacokinetics Blood - GW856553

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, Atherosclerosi

Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Serious Adverse Event (SAE)

- 12/12/18 - 1 form, 13 itemgroups, 62 items, 1 language

Itemgroups: Administrative data, Section 1 Serious Adverse Events, Section 2 Seriousness, Section 3 Demography Data, Section 4 Recurrence of Adverse event after further investigational product, SECTION 5 Possible Causes of SAE other than Investigational Product(s), Section 6 Relevant Medical Conditions, SECTION 7 Other Relevant Risk Factors, SECTION 8 Relevant Concomitant Medications, SECTION 9 Details of Investigational Product(s), SECTION 10 Details of Relevant Assessments, SECTION 11 Narrative Remarks, Section 12 Additional/Follow-up 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 form of SAE. It has to be filled in if the subject has experienced an SAE.

Serious Adverse Event (SAE) - GSK Milveterol COPD 100527

- 6/19/17 - 1 form, 7 itemgroups, 48 items, 1 language

Itemgroups: Demography, Serious adverse events, Relevant Medical Conditions, Details of lnvestigational Product(s), Relevant Concomitant Medications, Reporting lnvestigator, Additional or follow-up information

Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

Non-Serious Adverse Events - GSK Milveterol COPD 100527

- 6/19/17 - 1 form, 1 itemgroup, 12 items, 1 language

Itemgroup: Non-Serious adverse events

Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol 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 - 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

GSK Efficacy and safety of Fluticasone on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) NCT01009463 - Serious Adverse Event

- 4/5/18 - 1 form, 7 itemgroups, 47 items, 1 language

Itemgroups: Serious Adverse Event, Intensity Changes, concomitant medication, Relevant medical conditions/Risk factors, Relevant Diagnostic Results, Rechallenge, Investigational product

Study ID: 102871 Clinical Study ID: HZC102871 Study Title:HZC102871: 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: NCT01009463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Pulmonary Disease, Chronic Obstructive Documentation part: Serious Adverse Event

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