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

- 05.12.18 - 1 Formular, 1 Itemgruppe, 13 Datenelemente, 1 Sprache

Itemgruppe: 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

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Concomitant Medication

- 01.10.18 - 1 Formular, 1 Itemgruppe, 13 Datenelemente, 1 Sprache

Itemgruppe: Concomitant Agent

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

Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723 - Additional Forms - Medication

- 08.02.18 - 1 Formular, 1 Itemgruppe, 13 Datenelemente, 1 Sprache

Itemgruppe: Medication

Study ID: 100723 Clinical Study ID: AXR100723 Study Title: A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia; Avandia XR; Avandia XR,Rosiglitazone XR,Avandia; Rosiglitazone XR Study Indication: Diabetes Mellitus, Type 2 Documentation part: Additional Forms - Medication

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Pancreatitis Patient Data

- 19.11.18 - 1 Formular, 8 Itemgruppen, 41 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Pancreatitis, Alcohol, Family History of Pancreatitis, Recent Trauma/Vascular Invasive Procedures or Surgery, Concomitant Medications, Symptoms of Gatrointestinal Illness Associated with Pancreatitis, Other Symptoms Associated with Pancreatitis

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 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

End period - Medications, Adverse Events, Transfusion History, Conclusion and Termination UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 15.03.21 - 1 Formular, 4 Itemgruppen, 32 Datenelemente, 2 Sprachen

Itemgruppen: Medications, Adverse Events, Transfusion history during the entry study, Conclusion of the Study and Termination

Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Adverse Events/ Serious Adverse Events; Prior and Concomitant Medications/ Non-drug Therapies

- 29.11.20 - 1 Formular, 15 Itemgruppen, 57 Datenelemente, 1 Sprache

Itemgruppen: Administrative, Adverse Events, Adverse Events/ Serious Adverse Events - Section 1, Adverse Events/ Serious Adverse Events - Section 2 (Seriousness), Adverse Events/ Serious Adverse Events - Section 3 (Demography Data), Adverse Events/ Serious Adverse Events - Section 4, Adverse Events/ Serious Adverse Events - Section 5, Adverse Events/ Serious Adverse Events - Section 6 (Medical Conditions), Adverse Events/ Serious Adverse Events - Section 7 (Other RELEVANT Risk Factors) , Adverse Events/ Serious Adverse Events - Section 8 (RELEVANT Concomitant Medications) , Adverse Events/ Serious Adverse Events - Section 9 (Details of Investigational Product(s)) , Adverse Events/ Serious Adverse Events - Section 10 (Details of RELEVANT ASSESSMENTS) , Adverse Events/ Serious Adverse Events - Section 11 (Narrative Remarks), Prior and Concomitant Medications/Non-drug Therapies , Prior and Concomitant Medications/Non-drug Therapies

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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Prior Concomitant Medications and Non-Drug Therapies

- 14.11.18 - 1 Formular, 3 Itemgruppen, 20 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Prior Medications and Therapies, If Yes, add details on next page (includes over-the counter and prescription drugs) below

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 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 an oral contraceptive co-administered with Albiglutide in women - 107032 - Visit 20: Prior and Concomitant Medications + Gen-consent

- 20.12.18 - 1 Formular, 5 Itemgruppen, 31 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Prior and Concomitant Medications/Non-Drug Therapies, PGx-Pharmacogenetic Research Consent, Blood Sample, PGx-Pharmacogenetic Research Consent Withdrawal

Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 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

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Concomitant Medications

- 24.05.20 - 1 Formular, 3 Itemgruppen, 16 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Concomintant Medications, List of Concomintant Medications

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Concomitant Medications has to be filled in at the Screening Visit and throughout the study whenever a change in patient's medication is made.

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Adverse Events Form

- 14.11.18 - 1 Formular, 13 Itemgruppen, 49 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Adverse Events/Serious Adverse Event, Section 1, Section 2 - Seriousness, Section 3 - Demography Data, Section 4, Section 5, Section 6 - Relevant Medical Conditions, Section 7 - Relevant Risk Factors, Section 8 - Relevant Concomitant Medications, Section 9 - Investigational Product, Section 10 - Relevant Assessment, Section 11 - Narrative Remarks

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 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

Throughout: Concomitant Medication 2A [CM_2A] NCT01117584

- 04.02.17 - 1 Formular, 1 Itemgruppe, 21 Datenelemente, 1 Sprache

Itemgruppe: General Information

NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

CONCOMITANT MEDICATIONS (MONTH 13 - MONTH 24) CRFs Roche FVF4170G Macular Edema NCT00473382

- 25.06.17 - 1 Formular, 3 Itemgruppen, 11 Datenelemente, 1 Sprache

Itemgruppen: Patient administration, CONCOMITANT MEDICATIONS (DAY 0 - MONTH 12), Medication

Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

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