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 @ 11:48 PM
Ignite Modification Date: 2025-12-25 @ 9:42 PM
NCT ID: NCT04575051
Description: This study was considered exempt from collecting data on adverse events due to the nature of the intervention and the data being collected. Deaths were recorded but not required to be documented as serious adverse events per the Institutional Review Board.
Frequency Threshold: 0
Time Frame: 25 months from study start (Time Point 0 through Time Point 5)
Study: NCT04575051
Study Brief: Hearing for Communication and Resident Engagement
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 5 (2 Residential Facilities) Participants in these facilities had the Consult Model for Time Periods 0-4 then started the HearCARE program at Time Period 5. 24 None 0 0 0 0 View
Group 1 (2 Residential Facilities) Participants in these facilities had the Consult Model for Time Period 0 then started the HearCARE program at Time Period 1 and continued with the HearCARE program through Time Period 5. 25 None 0 0 0 0 View
Group 2 (2 Residential Facilities) Participants in these facilities had the Consult Model for Time Periods 0 and 1 then started the HearCARE program at Time Period 2 and continued with the HearCARE program through Time Period 5. 23 None 0 0 0 0 View
Group 3 (2 Residential Facilities) Participants in these facilities had the Consult Model for Time Periods 0, 1 and 2 then started the HearCARE program at Time Period 3 and continued with the HearCARE program through Time Period 5. 53 None 0 0 0 0 View
Group 4 (2 Residential Facilities) Participants in these facilities had the Consult Model for Time Periods 0, 1, 2, and 3 then started the HearCARE program at Time Period 4 and continued with the HearCARE program through Time Period 5. 20 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):