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 @ 10:48 PM
Ignite Modification Date: 2025-12-25 @ 8:17 PM
NCT ID: NCT04112069
Description: None
Frequency Threshold: 0
Time Frame: Up to 2 months for the RCT (Randomized control trial)
Study: NCT04112069
Study Brief: The Insulin-Only Bionic Pancreas Bridging Study- Pediatric Transitional 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 Participants randomized to usual care first started the usual care arm (UC) managing their diabetes with continuous subcutaneous insulin infusion (pump therapy) for approximately 5 days. All subjects wore a Dexcom G5 continuous glucose monitor (CGM). If randomized to the usual care arm first, subjects crossed over to the bionic pancreas arm following a 2-day washout period. Usual Care: Usual care 0 None 0 20 0 20 View
iLet Bionic Pancreas With Humalog or Novolog Participants randomized to the iLet with humalog/novolog first started the insulin-only iLet arm using the insulin analog that they use for their usual care (either Humalog or Novolog) for approximately 5 days. All subjects wore a Dexcom G5 CGM. If randomized to the bionic pancreas arm first, subjects crossed over to the usual care arm following a 2-day washout period. iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog: iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog 0 None 0 20 3 20 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