REAL-WORLD TREATMENT AND OUTCOME PATTERNS IN R/RDLBCL PATIENTS IN THIRD LINE AND BEYOND: A DANISH POPULATION-BASED STUDY - Research Plan - Version 4.0

Sep 12, 2026

Research plan for an RWE scientific project evaluating real-world treatment and outcome patterns in patients with refractory or relapsed DLBCL (R/RDLBCL) in third line and beyond using a Danish population-based approach. The document specifies project identifier SG43837, version and template basis, outlines milestones for dataset creation through publication submission, and defines research questions, objectives, methods, data sources, variables, endpoints, statistical considerations, documentation, and study limitations. It also covers human protection, consent and regulatory compliance, and plans for dissemination and adverse event management.

LanguageEnglish

CategoryForms

FormatPDF

Pages65

Reading Time23 min

AccessFree to download

Table of Contents

List of abbreviations

Research team

Amendments and updates

Milestones

Research question and objectives

Research methods

Protection of human patients

Plans for dissemination and communication of research results

Management and reporting of adverse events

Retention of records

References

Appendix 1 REDCap eCRF

Based on Research Plan template Version 4.0 released on 26 Feb 2021 RESEARCH PLAN (RWE SCIENTIFIC PROJECT) | TITLE: | REAL-WORLD TREATMENT AND OUTCOME PATTERNS IN R/RDLBCL PATIENTS IN THIRD LINE AND BEYOND: A DANISH POPULATION-BASED STUDY | | --- | --- | | PROJECT NUMBER: | SG43837 | | VERSION NUMBER: | 1.0 | | STUDIED MEDICINAL PRODUCT: | None | | RESEARCH INITIATOR: | Ashwini Shewade
Genentech, Inc (a member of Roche)
1 DNA Way, South San Francisco
CA 94080 | | AUTHOR: | Thomas Stauffer Larsen MD PhD Department of Hematology Odense University of Hospital 5000 Odense C Denmark
[thomas.stauffer.larsen@rsyd.dk](thomas.stauffer.larsen@rsyd.dk)
Ashwini Shewade
Principal Data Scientist, RWD Enabling Platform PD Data Sciences
Genentech, a member of Roche
[shewadea@gene.com](shewadea@gene.com) | | DATE FINAL: | See electronic date stamp below | Date and Time (UTC) 21-Dec-2021 17:39:02 Title CMD Approver's Name Flahavan, Eva (flahavae) Based on research plan template Version 4.0 released on 26 Feb 2021 TABLE OF CONTENTS 1. LIST OF ABBREVIATIONS 3 2. RESEARCH TEAM 5 3. AMENDMENTS AND UPDATES 6 4. Milestones 7 5. Research Question and Objectives 8 6. Research methods 9 6.1 Data Source(s) 9 6.2 Setting 9 6.3 Variables and Endpoints 10 6.3.1 Study Variables 10 6.3.2 Endpoints 11 6.4 Research Size 11 6.5 Data Management 11 6.5.1 Data Quality Assurance 12 6.6 Data Analysis and other statistical considerations 12 6.7 Research Documentation 12 6.8 Limitations of the research method 13 7. Protection of human patients 13 7.1 Informed Consent 13 7.2 Compliance with Laws and Regulations 13 7.3 Institutional Review Board or Ethics Committee 14 8. PLANS FOR DISSEMINATION AND COMMUNICATION OF RESEARCH RESULTS 14 9. Management and Reporting of Adverse Events 14 10. Retention of Records 14 11. References 15 Appendix 1 REDCap eCRF 17 F. Hoffmann-La Roche Ltd Research Plan SG43837, Version 1.0 Based on Research Plan template Version 4.0 released on 26 Feb 2021 1. LIST OF ABBREVIATIONS | Abbreviation Definition | | | --- | --- | | ALAT
ASCT
C
CAR
CHOEP
CNS
COO
CR
CRP
CSF
CT
DA-EPOCH
DLBCL
EC
ECOG
eCRF
eGFR
FDA
FISH
GPP
H
HGBCL
IPI
IRB
LDH
LVEF
LYFO
mAB
MAIC
NHL
NOS
NYHA
O | Alanin aminotransferase Autologous stem cell transplantation Cyclophosphamide
Chimeric antigen receptor
Cyclophosphamide, doxorubicin, vincristine, etoposide, prednisone
Central nervous system Cell of origin Complete response
c-reactive protein Cerebrospinal fluid Computed tomography
Dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin
Diffuse large B-cell lymphoma Ethics Committee
Eastern Cooperative Oncology Society Electronic case report form Estimated glomerular filtration rate Food and Drug Administration Florescence in situ hybridization
Good Pharmacoepidemiological Practice Doxorubicin
High grade B-cell lymphoma International prognostic index Institutional Review Board
Lactate dehydrogenase
Left ventricular ejection fraction The Danish National Lymphoma Registry Monoclonal antibody
Matching-adjusted indirect comparison Non-Hodgkin’s Lymphoma Not otherwise specified
New York Heart Association Vincristine | F. Hoffmann-La Roche Ltd Research Plan SG43837, Version 1.0 Based on research plan template Version 4.0 released on 26 Feb 2021 | Abbreviation | Definition | | --- | --- | | ORR | Overall response rate | | OS | Overall survival | | P | Prednisone | | PD | Progressive disease | | PET/CT | Positron emission tomography and computed tomography | | PFS | Progression-free survival | | PI | Principle investigator | | PMBCL | Primary mediastinal B-cell lymphoma | | R | Rituximab | | R-CHOP | Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone | | R/R | Refractory or relapsed | | SCT | Stem cell t

FAQs

What study population and setting are targeted in this research plan?

Patients with refractory or relapsed DLBCL in third line and beyond are studied using a Danish population-based approach.

What is the project number and version referenced in the plan?

The project number is SG43837 and the document is labeled Research Plan SG43837, Version 1.0, based on the template Version 4.0 released on 26 Feb 2021.

Which major research topics are covered beyond methods?

The plan includes milestones, research questions and objectives, protection of human patients (consent and regulatory compliance), dissemination and communication, adverse event management, retention of records, and references, plus an appendix for REDCap eCRF.

Sep 12, 2026

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