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 @ 4:20 PM
Ignite Modification Date: 2025-12-25 @ 2:16 PM
NCT ID: NCT01519466
Description: None
Frequency Threshold: 5
Time Frame: Adverse events collected from enrolment to completion by last subject (up to 3 months).
Study: NCT01519466
Study Brief: Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot 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
FreeStyle Freedom Lite Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study. FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter None None 2 16 4 16 View
FreeStyle InsuLinx Subjects will use a FreeStyle InsuLinx blood glucose meter during the study FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature. None None 3 33 8 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Haematoma NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Middle ear effusion NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Gingiva abcess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fractured Metacarpus NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sensor tip NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cold NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View