Other Event

Other Event

Other Adverse Events are non-serious adverse events that exceed a specific frequency threshold (typically 5% within any study arm). These events are reported to provide comprehensive safety information about all noteworthy adverse occurrences during clinical trials. Each other event is categorized by term, organ system, assessment type, and source vocabulary for standardized reporting.

Other Event path is as follows:

Study -> Results Section -> Adverse Events Module -> Other Event

Study -> Results Section -> Adverse Events Module -> Other Event -> Other Event Stats

Other Event


Ignite Creation Date: 2025-12-25 @ 5:04 AM
Ignite Modification Date: 2025-12-26 @ 4:07 AM
NCT ID: NCT04577118
Term: Incision coming open at CI site as seen at 2-week post-op visit.
Organ System: Ear and labyrinth disorders
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
Source Vocabulary: None
Notes: Physician addressed by adding small additional suture. At subsequent visit (activation), healing issue resolved and activation occurred. This is identified risk of cochlear implantation surgery as captured in labeling and literature
Study: NCT04577118
Study Brief: The iotaSOFT Insertion System Safety Study
Other Event Stats (If Any):

Other Event Stats

Group ID # Events # Affected # At Risk View
EG000 1 1 21 View