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 @ 2:28 AM
Ignite Modification Date: 2025-12-26 @ 1:02 AM
NCT ID: NCT02886234
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were monitored throughout the trial, starting at baseline and continuing through the initial pill count phase of baseline (2 months), the intervention period (2 months), and during the 3-month follow-up period (3 months). Thus, adverse events were monitored for a total of 7 months.
Study: NCT02886234
Study Brief: Health Improvement Project - Providence
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Health Coaching (HC) Eight, 30-minute phone delivered HC sessions once a week for 8 weeks Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics 0 None 0 22 0 22 View
Mindfulness Training (MT) Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor. 0 None 0 20 0 20 View
Serious Events(If Any):
Other Events(If Any):