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 @ 2:01 PM
Ignite Modification Date: 2025-12-25 @ 12:46 PM
NCT ID: NCT00891995
Description: None
Frequency Threshold: 2
Time Frame: 1 year
Study: NCT00891995
Study Brief: Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intensive Treatment The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years. None None 2 48 6 48 View
Standard Treatment The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years. None None 1 20 2 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anaphylactic reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
severe hypoglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
venous thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
faint NON_SYSTEMATIC_ASSESSMENT General disorders None View
skin infection NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
depression and anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Needle stick/puncture NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View