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

HSCT recipients - Cause of death

- 9/20/21 - 1 form, 9 itemgroups, 24 items, 1 language

Itemgroups: Registry Use Only, Identification Data, HSCT Type , Product Type, Death Date, Autopsy report, Primary Cause of Death, Secondary Cause of Death, Author Information

To define the primary and contributing causes of death for HSCT recipients reported as dead on follow up forms 2900 - RECIPIENT DEATH DATA Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6B9DD88E-9E08-08A7-E040-BB89AD430716

Sentinel Common Data Model Cause of Death

- 8/25/19 - 1 form, 1 itemgroup, 6 items, 1 language

Itemgroup: Cause of Death

Sentinel: Overview and Description of the Common Data Model v7.0.0 "The primary goal of Sentinel is to build and operate a national public health surveillance system to monitor the safety of FDA-regulated medical products, including drugs, biologics, and devices. Sentinel is part of the Sentinel Initiative, the FDA’s response to a congressional mandate to create an active surveillance system using electronic health data.The Sentinel program will undertake three major types of activities: (1) prospective evaluation of accumulating experience about specific medical products and specific suspected safety problems; (2) evaluation of the impact of FDA actions (e.g., labeling changes) on medical practice and health outcomes; and (3) rapid assessment of past experience in response to FDA questions about specific exposures and outcomes." For more information about Sentinel visit the website at: www.sentinelsystem.org For comments and suggestions, please email: info@sentinelsystem.org The SCDM Cause of Death Table contains one record per unique combination of PatID and COD.1,2 When legacy data have conflicting reports, please make a local determination as to which to use. There is typically a 1-2 year lag in death registry data. Note: For efficiency death data is captured in 2 tables: Death: the record that characterizes the death date and source of that information Cause of Death: the cause(s) of death associated with the death record These 2 tables are linked by PatID. All Cause of Death records have a matching PatID in the Death Table. PatID is a pseudoidentifier with a consistent crosswalk to the true identifier retained by the source Data Partner. For analytical data sets requiring patient-level data, only the pseudoidentifier is used to link across all information belonging to a patient.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Form D

- 4/15/19 - 1 form, 2 itemgroups, 9 items, 1 language

Itemgroups: Administrative data, Form D

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Form D. It can be filled in for the end of study.

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Adjudication Events - Death

- 1/7/19 - 1 form, 10 itemgroups, 61 items, 1 language

Itemgroups: Administrative data, Death, Cause of Death, Classification of Primary Cause of Death, Non-cardiovascular death, Cardiovascular death, Place of Death, Other data, Circumstances of Death, Narrative

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

German Hodgkin Study Group Study HD16/HD17/HD18 Final Report DRKS00003455 DRKS00003457 - Deutsche Hodgkin Studiengruppe: Abschlussbogen

- 11/1/18 - 1 form, 2 itemgroups, 23 items, 1 language

Itemgroups: Form Header, Death report

HD16 NCT Nr.: NCT00736320 HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET. This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS). HD17 NCT Nr.: NCT01356680 HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma.This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of progression free survival (PFS). HD18 NCT Nr.: NCT00515554 HD18 for Advanced Stages in Hodgkins Lymphoma. This study is designed to test: in patients with negative positron-emission tomography (PET) after 2 cycles of BEACOPPesc chemotherapy: whether the number of cycles can be reduced without compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles) for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc chemotherapy by adding Rituximab improves PFS. Permission granted by: Andreas Engert, M.D. Chairman, German Hodgkin Study Group Professor for Internal Medicine Hematology & Oncology University Hospital of Cologne Department of Internal Medicine I Kerpener Str. 62 D-50924 Köln Phone: +49-221-478-5933/5966 Fax: +49-221-478-3778 a.engert@uni-koeln.de

Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857 - Serious adverse events, Form D and Vitals

- 2/26/18 - 1 form, 8 itemgroups, 47 items, 1 language

Itemgroups: Administration, Serious adverse experience, Form D, Orthostatic vital signs, Dose and meal information, Medical Procedures, Concomitant Medication, Adverse experiences

Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome; Restless Legs Syndrome (RLS)