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

- 30.11.18 - 1 Formular, 1 Itemgruppe, 5 Datenelemente, 1 Sprache

Itemgruppe: 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

Advanced Chronic Myelogenous Leukemia (CML) NCT00123487- End of Treatment - Supplemental page

- 06.08.15 - 5 Formulare, 22 Itemgruppen, 81 Datenelemente, 1 Sprache

Itemgruppen: EXCEPTION, PREVIOUS AND CURRENT MEDICATIONS, PRE-TREATMENT EVENTS, BONE MARROW BIOPSY/ ASPIRATE, ELECTROCARDIOGRAM, CHEST X-RAY, TRANSFUSIONS, FLUORESCENT IN SITU HYBRIDIZATION, EXTERNAL DATA TRACKING, LABORATORY TEST RESULTS, DRUG DISPENSATION, BMS-354825 DOSING, CONCOMITANT MEDICATIONS, NON-SERIOUS ADVERSE EVENTS, DEATH DATA, ENROLLMENT IN PREVIOUS BMS CA180 PROTOCOL, DOSE ADMINISTRATION FOR UNSCHEDULED CSF, CSF PHARMACOKINETICS, BLOOD PHARMACOKINETICS, DOSE ADMINISTRATION, PLEURAL OR OTHER BODY FLUID PHARMACOKINETICS, DIAGNOSTIC PROCEDURES

Study documentation part: End of treatment. This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).Trial Number: NCT00123487. Drug: dasatinib. Phase 3

Advanced Chronic Myelogenous Leukemia (CML) NCT00123487- End of Treatment

10 Itemgruppen 46 Datenelemente

Serious Adverse Event (SAE)- Form

3 Itemgruppen 36 Datenelemente

Pharmacokinetics

4 Itemgruppen 22 Datenelemente

Follow- Up

3 Itemgruppen 11 Datenelemente

Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138 - Concomitant Medications, Asthma Exacerbations, IP Device Malfunction, Chest X-Ray, Pharmacogenetic Research Consent/ Sample Collection, Investigational Product Compliance and Unsceduled Asthma related Healthcare Resource Utilisation - Subject Logs

- 17.11.18 - 1 Formular, 9 Itemgruppen, 81 Datenelemente, 1 Sprache

Itemgruppen: Concomitant Medication, Asthma Exacerbations, Contact Method/ Treatment site for ExacerbationsMethod, Exacerbation Medications, IP Device Malfunction, Chest X-Ray, Pharmacogenetic (PGx) Research Consent/ Sample Collection, Investigational Product Compliance, Unscheduled Asthma related Healthcare Resource Utilisation

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

Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – On- Treatment

- 18.11.21 - 9 Formulare, 1 Itemgruppe, 3 Datenelemente, 1 Sprache

Itemgruppe: Subject details

Study documentation part: On- Treatment This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).Trial Number: NCT00123487. Drug: dasatinib. Phase 3

On-Treatment 1

15 Itemgruppen 84 Datenelemente

On-Treatment 2

13 Itemgruppen 62 Datenelemente

On-Treatment 4

12 Itemgruppen 62 Datenelemente

On-Treatment 6

12 Itemgruppen 62 Datenelemente

On-Treatment 7

13 Itemgruppen 67 Datenelemente

On-Treatment 8

13 Itemgruppen 67 Datenelemente

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Concomitant Medication BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 17.06.16 - 1 Formular, 2 Itemgruppen, 14 Datenelemente, 1 Sprache

Itemgruppen: Subject Identification, Concomitant Medication list

The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Concomitant Medication

ToFingo Screening V1 Previous and concomitant medication non drug therapies NCT02325440

- 13.06.16 - 1 Formular, 2 Itemgruppen, 9 Datenelemente, 1 Sprache

Itemgruppen: Study administration, Previous and concomitant medication

Principal Investigator: Luisa Klotz Collaborator: Novartis Information provided by (Responsible Party):University Hospital Muenster -Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya (ToFingo2) Purpose A trial in patients with relapsing remitting multiple sclerosis (RRMS) Main objectives: •To evaluate changes in the reconstitution of immune surveillance over time upon switching from natalizumab to fingolimod assessed by a change in the expression of CD49d. •To evaluate changes in the migratory capacity of immune cells/peripheral blood mononuclear cells (PBMCs) upon switching from natalizumab to fingolimod in an in-vitro model of the blood-brain-barrier (BBB). •To evaluate changes in paraclinical disease activity over time upon switching from natalizumab to fingolimod assessed by MRI (changes in Gd+, T2w lesions and DTI). •To evaluate changes in T1w / FLAIR lesions upon switching from natalizumab to fingolimod. For further Information please visit https://clinicaltrials.gov/ct2/show/NCT02325440

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 Formular, 20 Itemgruppen, 128 Datenelemente, 1 Sprache

Itemgruppen: 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

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Cumulative documentation - Medication (Kumulative Dokumentation - Medikation)

- 23.03.20 - 1 Formular, 2 Itemgruppen, 14 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Medication

DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the cumulative documentation - medication. Prior medication should be filled in at baseline. Medication that are performed during the study period should be added in the course of the study.

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