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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Period 1: Study 1 | Twenty experienced single-sided deaf cochlear implant recipients (SSD-CI) compared their everyday speech processor program frequency allocation table (FAT) to a modified FAT. The modified FAT was created to reduce interaural frequency mismatch between the normal hearing ear and the cochlear implant ear. Participants were first tested with their everyday FAT. They were tested a second time after 6 weeks use of the modified FAT. Lastly, they compared both FATs on their speech processor at home for several weeks, after which they were tested a second time with each FAT. | 0 | None | 0 | 20 | 0 | 20 | View |
| Period 2: Study 2 | Ten newly implanted single-sided deaf cochlear implant recipients (SSD-CI) participated. They compared the manufacturer's default FAT to a modified FAT. The modified FAT was created to reduce interaural frequency mismatch between the normal hearing ear and the cochlear implant ear. Five participants were assigned the manufacturer's default FAT at initial activation. Five were assigned to the modified FAT at initial activation. After 6 weeks use of the default or modified FAT, participants were tested and then began using the FAT that they had not been using, for another 6 weeks. Participants were tested again at the end of six weeks. They were tested a third time after comparing both FATs for several weeks. | 0 | None | 0 | 10 | 0 | 10 | View |
| Period 3: Study 3 | Fifteen experienced SSD-CI recipients compared their everyday speech processor program to a modified loudness speech processor program. The modified loudness program was created in an attempt to balance loudness between the normal hearing ear and the cochlear implant ear and therefore decrease interaural loudness mismatch. Participants were first tested with their everyday program. They were tested a second time after 6 weeks use of the modified program. Lastly, they compared both programs on their speech processor at home for several weeks, after which they were tested a second time with each program. | 0 | None | 0 | 15 | 0 | 15 | View |