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 @ 4:25 PM
Ignite Modification Date: 2025-12-25 @ 2:19 PM
NCT ID: NCT03565666
Description: None
Frequency Threshold: 0
Time Frame: Up to 2 months for the RCT
Study: NCT03565666
Study Brief: The Insulin-Only Bionic Pancreas Bridging Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Usual Care Arm Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm Usual care: Usual care 0 None 0 36 4 36 View
iLet With Humalog/Novolog Arm Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm 0 None 0 36 15 36 View
iLet Using Fiasp Arm Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm 0 None 1 36 16 36 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Serious adverse event SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Non-serious adverse event SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Non serious adverse event SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Non-serious adverse event SYSTEMATIC_ASSESSMENT Endocrine disorders None View