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Concomitant Medications Genzyme Chronic Kidney Disease EudraCT 2005-003233-41

- 18/09/16 - 1 modulo, 2 itemgroups, 10 elementi, 1 linguaggio

Itemgroups: Patient administration, Concomitant Medications

An open label, dose titration study of sevelamer carbonate tablets dosed three times a day in hyperphosphatemic chronic kidney disease patients not on dialysis Name of Sponsor: Genzyme Europe BV Country: Netherlands https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-003233-41/DE#A

Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181 - Concomitant Medications

- 05/12/18 - 1 modulo, 1 ItemGroup, 13 elementi, 1 linguaggio

ItemGroup: Concomitant Agent

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

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Liver Events Form

- 07/12/18 - 1 modulo, 2 itemgroups, 13 elementi, 1 linguaggio

Itemgroups: Liver Events, Investigational Product (Liver)

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

Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138 - Visit Assessments Complete (Visit 2) and Run-In-Failure, Randomisation Criteria, ICS/ LABA Concomitant Medications, Randomisation Number, Investigational Product, Vital Signs, Electronically Transferred Lab Data, Device Use Assessment, Subject Withdrawal Status and Liver Events Assessment(Visit 3)

- 21/11/18 - 1 modulo, 18 itemgroups, 47 elementi, 1 linguaggio

Itemgroups: Date of Visit/ Assessment , Completion of Visit Assessments, Run- In Failure, Investigator Siganture , Date of Visit/ Assessment , Randomisation Criteria, Run- In Failure , Investigator Siganture , ICS/ LABA Concomitant Medications, Randomisation Number, Investigatinal Product, Vital Signs, Candidiasis Examination, Electronically transferred lab data, Device Use Assessment, Subject Withdrawal Status, Electronically transferred lab data , Liver Events Assessment

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

Concomitant Medications - GSK Milveterol COPD 100527

- 19/06/17 - 1 modulo, 1 ItemGroup, 14 elementi, 1 linguaggio

ItemGroup: Concomitant Medications

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

Kidney Cancer NCT00326898 Treatment - E2805 Concomitant Medication Form - 2444090v1.0 - E2805 Concomitant Medication Form

- 14/07/17 - 1 modulo, 3 itemgroups, 34 elementi, 1 linguaggio

Itemgroups: Administrative documentation, Concomitant medication, Comments

E2805 Concomitant Medication Form Sunitinib or Sorafenib in Treating Patients With Kidney Cancer That Was Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0B593E1B-ACB3-37BB-E044-0003BA3F9857

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Concomitant Medications Form

- 30/10/19 - 1 modulo, 1 ItemGroup, 22 elementi, 1 linguaggio

ItemGroup: Concomitant Medication Details

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

concomitant medication salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

- 08/08/17 - 1 modulo, 5 itemgroups, 23 elementi, 1 linguaggio

Itemgroups: administrative data, COPD concomitant medication, COPD concomitant medication documentation, concomitant medication, concomitant medication

Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

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

- 27/10/18 - 1 modulo, 20 itemgroups, 128 elementi, 1 linguaggio

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

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Log Status Form

- 30/11/18 - 1 modulo, 1 ItemGroup, 5 elementi, 1 linguaggio

ItemGroup: Log Status

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

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Concomitant Medication

- 19/08/19 - 1 modulo, 2 itemgroups, 11 elementi, 1 linguaggio

Itemgroups: Administrative documentation, Concomitant Agent

Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Initial Serious Adverse Event Form

- 30/11/18 - 1 modulo, 10 itemgroups, 61 elementi, 1 linguaggio

Itemgroups: Randomisation, Serious Adverse Event Entry, Seriousness, Relevant Concomitant/Treatment Medication, Relevant Medical Conditions/Risk Factors, Relevant Diagnosis Results, Rechallenge, Investigational Product, General narrative comments, Non Clinical

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

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