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 @ 11:08 PM
Ignite Modification Date: 2025-12-25 @ 8:40 PM
NCT ID: NCT02836769
Description: The risk of serious adverse events, mortality, and other adverse events was low because the study tested a behavioural intervention. Definitions of adverse events are in alignment with the Clinicaltrials.gov definitions.
Frequency Threshold: 0
Time Frame: Adverse event data were collected during the 15 months when study participants were enrolled.
Study: NCT02836769
Study Brief: Development and Evaluation of Rehabilitation Consult for Survivors of Head and Neck Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rehabilitation Consult (RC) Pilot testing: single group pre-post design Rehabilitation Consult (RC): The RC was designed to foster key contributors to self management in the participants. The RC is administered by a rehabilitation professional and consists of an initial one-hour face-to-face consult and follow-up appointment(s) 2-12 weeks later, either telephone or face-to-face. The initial consult consists of orientation, consultation, goal-setting, teaching cognitive strategies, introduction to online resources/action planning/planning coping responses, review/implementation intentions/scheduling follow-up. The follow-up consists of a reminder, reorientation, checking of progress on goals and plans, re-planning as necessary, and discharge or scheduling of further follow-up as necessary. 0 None 0 30 0 30 View
Serious Events(If Any):
Other Events(If Any):