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: 2025-12-25 @ 2:18 AM
Ignite Modification Date: 2025-12-26 @ 12:48 AM
NCT ID: NCT05204134
Description: None
Frequency Threshold: 0
Time Frame: 15 weeks
Study: NCT05204134
Study Brief: Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MDI Run-In With CGM Run-In with MDI therapy and CGM for 2 weeks. 0 None 0 33 0 33 View
Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals through 13 weeks of use. 0 None 2 33 8 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Severe Hypoglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ketonemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Edema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View