Throughout this document, "potential gastroparesis events" has been used to refer to any of the events that met the search criteria for gastroparesis events as defined by the following Medical Dictionary for Regulatory Activities (MedDRA) preferred terms of

• bezoar
• diabetic gastroparesis
• diabetic gastropathy
• endoscopy upper gastrointestinal tract
• endoscopy upper gastrointestinal tract abnormal
• gastric atony
• gastric emptying study
• gastric hypomotility
• gastric residual increased
• gastrointestinal hypomotility
• gastrointestinal motility disorder
• gastroparesis postoperative
• impaired gastric emptying, and
• regurgitation.2

In order to identify potential events of gastroparesis, an intentionally broad search strategy was utilized that included diagnostic tests, symptoms, and sequelae that may be associated with gastroparesis. As a result, some adverse events may be included that are not gastroparesis. There were no events of bezoar, endoscopy upper gastrointestinal tract abnormal, gastric atony, gastric emptying study, gastric residual increased, or gastroparesis postoperative identified in the search of the clinical trial database.2

The clinical trial database was searched for potential gastroparesis events across all 27 completed controlled phase 2, 3, and 4 studies of dulaglutide as of October 31, 2023.2

Postmarketing data do not necessarily represent the rate of occurrence of an adverse event in a treated population, but they represent a reporting rate of a particular adverse event to the company. Spontaneous reporting of adverse events can be highly variable and is not appropriately controlled clinical information on which to base an assessment of whether a particular drug product is the causal agent of an adverse event.2

Spontaneous reporting has limited use due to

• lack of control population
• under-reporting or reporting bias, and
• missing or incomplete information regarding patient's medical history or concomitant medications.2

The Eli Lilly and Company (Lilly) spontaneous adverse event database may also include reports of adverse events for products that may be available from Lilly and from other manufacturers. Although verification of product manufacturer is sought, this verification is not always obtainable. The default for these cases is to include them in the database.2

Through September 18, 2023, adverse events with the MedDRA preferred terms of bezoar, diabetic gastroparesis, diabetic gastropathy, gastric atony, gastric hypomotility, gastric residual increased, gastrointestinal hypomotility, gastrointestinal motility disorder, impaired gastric emptying, and regurgitation have been Very Rarely Reported in the Lilly spontaneous adverse event database, based on the estimated exposure of 18,398,000 patients. Very Rarely Reported is defined as an adverse event that has been reported at an estimated rate of <0.01% according to the reporting system information.2

Adverse events with the preferred terms of endoscopy upper gastrointestinal tract, endoscopy upper gastrointestinal tract abnormal, gastric emptying study, and gastroparesis postoperative were not present in the Lilly spontaneous adverse event database through September 18, 2023.2

Patient safety is Eli Lilly and Company’s top priority, and we actively engage in monitoring, evaluating, and reporting safety information for all our medicines.