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 @ 7:10 PM
Ignite Modification Date: 2025-12-25 @ 4:44 PM
NCT ID: NCT04771403
Description: All participants that began/started the Dexcom training visit or an MPC or FMPD arm visit are included in the adverse events. The numbers from the participant flow indicate that 25 subjects began the Dexcom training visit, 25 subjects began an MPC visit and 24 subjects began an FMPD visit.
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT04771403
Study Brief: Two Way Crossover Closed Loop Study MPC vs FMPD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MPC AP System Participants will use the MPC AP system for automated insulin delivery for a 76 hour study visit. 0 None 0 25 1 25 View
FMPD AP System Participants will use the FMPD AP system for automated insulin delivery for a 76 hour study visit. 0 None 0 24 0 24 View
Dexcom G6 Training Arm Participants will use the Dexcom G6 CGM with the MPC AP algorithm for acquiring sensor glucose values. 0 None 0 25 1 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Back Sprain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
High ketones SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View