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Bayer Healthcare Pharmaceuticals, Inc.
Riociguat (BAY 63-2521)
Briefing Document for
Cardiovascular and Renal Drugs Advisory Committee
Riociguat (BAY 63-2521)
Reviewer’s Guide
This document provides 3 levels of review with increasing levels of detail:
1. Overview (page 12): Provides an extended review of key program characteristics, results,
and conclusions. References are provided to supporting sections, tables, and figures in the
Core Document.
2. Core Document (Sections 1 through 10 beginning on page 51): Includes detailed
summaries and discussions in support of the Overview.
3. Appendices (beginning on page 196): Provide descriptions of scales/questionnaires,
narratives for selected patients, and selected summary tables for individual, controlled,
phase 3 studies. These appendices are referenced in the Core Document when relevant.
This review structure allows review at varying levels of detail; however, reviewers who read at
multiple levels will necessarily encounter repetition of key materials across the levels.
For those reviewing this document in electronic format, references to table and figure are
electronically linked to the corresponding table or figure. For those reviewing this document in
paper format, the page number is provided when the table or figure is in a different section. Note
that variability among printers may cause page numbers of printed documents to differ slightly
from those provided.
06 August 2013 Advisory Committee Meeting
Standard Investigator's Brochure Format
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