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 @ 5:26 PM
Ignite Modification Date: 2025-12-25 @ 3:00 PM
NCT ID: NCT05255068
Description: The definition of adverse event and/or serious adverse event, used to collect adverse event information, is not different from the clinicaltrials.gov Definitions.
Frequency Threshold: 5
Time Frame: Adverse event were collected at 3 time points: baseline (T1), immediately post intervention (6 weeks post baseline, T2), and 6-week post intervention (12 weeks post baseline, T3).
Study: NCT05255068
Study Brief: OPTIMAL in NH Residents With Dementia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Staff Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection. 0 None 0 94 0 94 View
Residents Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff. 0 None 0 17 0 17 View
Families In this study, we were initially planning to recruit families for our Aim 1 to collect feedback on the OPTIMAL intervention. The fact that we recruited 94 staff (initially planned for 20 staff recruitment), which is much more than we planned, and we were able to collect feedback from these staff on the OPTIMAL intervention which helped refinement of the intervention. Our team agreed that we received adequate feedback to move to Aim 2 and 3 (testing the OPTIMAL intervention in NH staff and residents, where families were not included in the proposed study). Therefore, we did not enroll families as participants, but communicated with them regarding the refined OPTIMAL and engaged N=5 family members in this effort where they served as community stakeholders and no individual characteristics were needed to be collected (rather than study participants/subjects who need to consent to be enrolled and followed up over time). 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):