FHIR IG analytics| Package | hl7.fhir.uv.ebm |
| Resource Type | Composition |
| Id | Composition-568060.json |
| FHIR Version | R6 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: Composition 568060
version: 10; Last updated: 2026-08-05 15:16:08+0000
Profile: M11ReportSection03
Artifact Description:
Example of M11ReportSection03 Profile
ArtifactPublicationStatus: Active
url: https://fevir.net/resources/Composition/568060
identifier: FEvIR Object Identifier/568060
status: Final
type: CeSHarP Report
category: section3-estimands
date: 2026-08-05 15:16:08+0000
author: Brian S. Alper, MD, MSPH
title: M11 Report Section 3 (Trial Objectives and Associated Estimands) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example
custodian: Computable Publishing LLC
relatesTo
type: Derived from
target: A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example
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type: Cite As
target:
M11 Report Section 3 (Trial Objectives and Associated Estimands) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568060. Revised 2026-08-05. Available at: https://fevir.net/resources/Composition/568060. Computable resource at: https://fevir.net/resources/Composition/568060#json.
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