Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 6:33 PM
Ignite Modification Date: 2025-12-25 @ 4:03 PM
NCT ID: NCT02701257
Description: There were no participants at risk for Serious Adverse Events, All-Cause Mortality and any other adverse events in the arm using the iLet bionic pancreas with Xerisol glucagon, because that arm was not conducted.
Frequency Threshold: 0
Time Frame: During study visits up to 8 hours long
Study: NCT02701257
Study Brief: The iLet Introduction Study: A Feasibility Study of the iLet, a Fully Integrated Bihormonal Bionic Pancreas
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
iPhone Bionic Pancreas - Lilly Glucagon iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits. iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily 0 None 0 9 0 9 View
iLet Bionic Pancreas - Lilly Glucagon iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily 0 None 0 12 7 12 View
iLet Bionic Pancreas - Xerisol Glucagon iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. iLet bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol glucagon: A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump 0 None 0 0 0 0 View
iLet Infusion Set iLet infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. 0 None 0 5 0 5 View
Contact Detach Contact Detach infusion set: The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. 0 None 0 7 0 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View