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 @ 12:08 AM
Ignite Modification Date: 2025-12-25 @ 10:08 PM
NCT ID: NCT02122458
Description: This was a minimal risk study, so adverse events were not expected but recorded and reported if they occurred or were reported by participants.
Frequency Threshold: 0
Time Frame: Adverse events were queried for each individual participant per session from enrollment to completion of their participation in study and summarized yearly at IRB renewal, Adverse Events were collected for 6 months from all participants except for those enrolled in the Delayed Hearing Aid Treatment Arm/Group, which was assessed for up to 1 year.
Study: NCT02122458
Study Brief: Blast Exposed Veterans With Auditory Complaints
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Immediate Hearing Aid Treatment: Blast-exposed With PTSD This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months. 0 None 0 18 0 18 View
Delayed Hearing Aid Treatment: Blast-exposed Only This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting. 0 None 0 7 0 7 View
Non-treatment Diagnostic Testing: Blast-exposed Only This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. They were negative for significant PTSD. 0 None 0 45 0 45 View
Non-treatment Diagnostic Testing: PTSD Only This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group was negative for blast-exposure and hearing loss but positive for significant PTSD. 0 None 0 19 0 19 View
Immediate Hearing Aid Treatment: Blast-exposed Only This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months. 0 None 1 12 0 12 View
Non-treatment Diagnostic Testing: Normal This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group included neurotypical Veterans with normal hearing and were negative for blast-exposure and PTSD. 0 None 0 82 0 82 View
Non-treatment Diagnostic Testing: Blast-exposed With PTSD This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. 0 None 0 43 0 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Middle ear infection and mass SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Serious View
Other Events(If Any):