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 @ 12:38 AM
Ignite Modification Date: 2025-12-25 @ 10:48 PM
NCT ID: NCT04038567
Description: Adverse events: 1. death 2. hospitalization for any reason 3. Suicidal ideation as indicated by a response on the PHQ-9 item 9 as any response other than 0 ('never')
Frequency Threshold: 0
Time Frame: 3 months
Study: NCT04038567
Study Brief: Optimizing a Mobile Mindfulness Intervention for ICU Survivors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Therapist Introduction to Intervention, Standard Dose, and Therapist Response Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period. 1 None 2 32 1 32 View
Therapist Introduction to Intervention, High Dose, and App Response Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period. 0 None 5 31 1 31 View
App Introduction to Intervention, High Dose, and Therapist Response Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period. 0 None 6 30 0 30 View
Therapist Introduction to Intervention, High Dose, and Therapist Response Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period. 0 None 4 31 1 31 View
App Introduction to Intervention, Standard Dose, and Therapist Response Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period. 0 None 1 31 1 31 View
App Introduction to Intervention, High Dose, and App Response Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period. 1 None 3 32 1 32 View
App Introduction to Intervention, Standard Dose, and App Response Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period. 0 None 2 30 1 30 View
Therapist Introduction to Intervention, Standard Dose, and App Response Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period. 1 None 2 30 2 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Suicidal ideation (per PHQ-9 item 9) SYSTEMATIC_ASSESSMENT Psychiatric disorders None View