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 @ 3:04 PM
Ignite Modification Date: 2025-12-25 @ 1:26 PM
NCT ID: NCT02478359
Description: Adverse event monitoring focused on passive monitoring via the EMR, components of the primary composite outcome (all cause hospitalizations, observation stays, emergency department visits, and death) for all randomized patients. Only deaths are reported here as anticipated serious adverse events, not related to study procedures. All-cause acute care utilization events were also considered anticipated serious adverse events, not related to study procedures.
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT02478359
Study Brief: Walk On! Physical Activity Coaching
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Physical Activity Coaching (Walk On!) The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support. 117 None 502 1358 997 1358 View
Standard Care Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan 117 None 499 1349 963 1349 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
All-cause hospitalizations SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Observational Stays SYSTEMATIC_ASSESSMENT Investigations None View
Emergency Department Visits SYSTEMATIC_ASSESSMENT Investigations None View