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 |
|---|---|---|---|---|---|---|---|---|
| Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy | Stimdia Medical's pdSTIM L4300 leads will be inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance into every patient who satisfies the Inclusion/Exclusion criteria and is enrolled in the study. Percutaneous electrical phrenic nerve stimulation (PEPNS) therapy will be administered via the Stimdia Medical PEPNS Console for six 2-hour sessions at 8-hour intervals over 48 hours, or until the patient is weaned; whichever comes first. | 4 | None | 4 | 12 | 0 | 12 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Patient Death | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |