<custodian> <reference value="Organization/118079"/> <type value="Organization"/> <display value="Computable Publishing LLC"/> </custodian> <relatesTo> <type value="derived-from"/> <targetReference> <reference value="ResearchStudy/267245"/> <type value="ResearchStudy"/> <display value="A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example"/> </targetReference> </relatesTo> <relatesTo> <type value="cite-as"/> <targetMarkdown value="M11 Report Section 7 (Participant Discontinuation) 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 568064. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568064. Computable resource at: https://fevir.net/resources/Composition/568064#json."/> </relatesTo> <section> <title value="Participant Discontinuation of Trial Intervention and Discontinuation or Withdrawal from Trial"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218583"/> <display value="ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL"/> </coding> <text value="section7-participant-discontinuation"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[No text is intended here (heading only).]</div> </text> <section> <title value="Discontinuation of Trial Intervention for Individual Participants"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218584"/> <display value="ICH M11 Protocol Section 7.1 Discontinuation of Trial Intervention for Individual Participants"/> </coding> <text value="section7.1-discontinuation-of-trial-intervention"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[No text is intended here (heading only).]</div> </text> <section> <title value="Permanent Discontinuation of Trial Intervention"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218585"/> <display value="ICH M11 Protocol Section 7.1.1 Permanent Discontinuation of Trial Intervention"/> </coding> <text value="section7.1.1-permanent-discontinuation-of-trial-intervention"/> </code> <text> <status value="additional"/><div xmlns="http://www.w3.org/1999/xhtml"><p>See Section 7.2</p></div> </text> </section> <section> <title value="Temporary Discontinuation of Trial Intervention"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218586"/> <display value="ICH M11 Protocol Section 7.1.2 Temporary Discontinuation of Trial Intervention"/> </coding> <text value="section7.1.2-temporary-discontinuation-of-trial-intervention"/> </code> <text> <status value="additional"/><div xmlns="http://www.w3.org/1999/xhtml"><p>Not Applicable.</p></div> </text> </section> <section> <title value="Rechallenge"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218587"/> <display value="ICH M11 Protocol Section 7.1.3 Rechallenge"/> </coding> <text value="section7.1.3-rechallenge"/> </code> <text> <status value="additional"/><div xmlns="http://www.w3.org/1999/xhtml"><p>Not Applicable.</p></div> </text> </section> </section> <section> <title value="Participant Discontinuation or Withdrawal from the Trial"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218588"/> <display value="ICH M11 Protocol Section 7.2 Participant Discontinuation or Withdrawal from the Trial"/> </coding> <text value="section7.2-participant-withdrawal"/> </code> <text> <status value="additional"/><div xmlns="http://www.w3.org/1999/xhtml"><p>Patients will be discontinued in the following circumstances: • enrollment in any other clinical study involving an investigational product or enrollment in any other type of medical research judged not to be scientifically or medically compatible with this study • participation in the study needs to be stopped for medical, safety, regulatory, or other reasons consistent with applicable laws, regulations, and good clinical practice • investigator decision o the investigator decides that the patient should be discontinued from the study for any reason. If this decision is made because of an AE, SAE, or a severe hypoglycemia event, appropriate measures are to be taken. Lilly or its designee is to be alerted. • patient decision o the patient, or legal representative, requests to be withdrawn from the study Patients discontinuing from the study prematurely for any reason must complete AE and follow-up procedures as shown in the Schedule of Activities (Section 1.3) 7.2.1 Discontinuation of the Study Following the review of the safety data from the first 6 patients to complete Period 2 Day 1, the study will be stopped if deemed necessary for patient safety in the opinion of the Investigator and sponsor (Section 10.3.7). The study will be discontinued if Lilly or its designee judges it necessary for medical, safety, regulatory, or other reasons consistent with applicable laws, regulations, and GCP</p></div> </text> </section> <section> <title value="Management of Loss to Follow-Up"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218589"/> <display value="ICH M11 Protocol Section 7.3 Management of Loss to Follow-Up"/> </coding> <text value="section7.3-lost-to-follow-up"/> </code> <text> <status value="additional"/><div xmlns="http://www.w3.org/1999/xhtml"><p>A patient will be considered lost to follow-up if he or she repeatedly fails to return for scheduled visits and is unable to be contacted by the study site. Site personnel are expected to make diligent attempts to contact patients who fail to return for a scheduled visit or were otherwise unable to be followed up by the site.</p></div> </text> </section> </section> </Composition>

Generated Narrative: Composition 568064

version: 2; Last updated: 2026-05-30 22:59:15+0000

Profile: M11ReportSection07

ArtifactPublicationStatus: Active

url: https://fevir.net/resources/Composition/568064

identifier: FEvIR Object Identifier/568064

status: Final

type: CeSHarP Report

category: section7-participant-discontinuation

date: 2026-05-30 22:59:15+0000

author: Brian S. Alper, MD, MSPH

title: M11 Report Section 7 (Participant Discontinuation) 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

relatesTo
type: Cite As
target:
M11 Report Section 7 (Participant Discontinuation) 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 568064. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568064. Computable resource at: https://fevir.net/resources/Composition/568064#json.