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 @ 3:29 AM
Ignite Modification Date: 2025-12-26 @ 2:10 AM
NCT ID: NCT00574405
Description: None
Frequency Threshold: 5
Time Frame: 12 months
Study: NCT00574405
Study Brief: Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Multiple Daily Injection Therapy Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis. None None 0 12 10 12 View
Insulin Pump Therapy, Started at Diagnosis. Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis. None None 1 12 7 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitilized for treatment of Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders Other View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders other View
Pump malfunction SYSTEMATIC_ASSESSMENT Investigations Other View
pharyngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Other View
Vision change SYSTEMATIC_ASSESSMENT Eye disorders Other View
Abdominal pain/constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Other View
Infections SYSTEMATIC_ASSESSMENT Infections and infestations Other View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Other View
myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Other View