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 @ 1:26 AM
Ignite Modification Date: 2025-12-25 @ 11:37 PM
NCT ID: NCT03431493
Description: None
Frequency Threshold: 0
Time Frame: From enrollment until completion of end of intervention surveys or study drop out (4 months)
Study: NCT03431493
Study Brief: Behavioral Activation-Rehabilitation to Improve Depressive Symptoms & Physical Function After Acute Respiratory Failure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Behavioral Activation - Rehabilitation Behavioral Activation - Rehabilitation Behavioral Activation - Rehabilitation: Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant's exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week's goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant's progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12. 1 None 0 24 0 24 View
Usual Care Control Usual Care Control 2 None 0 28 0 28 View
Serious Events(If Any):
Other Events(If Any):