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 |
|---|---|---|---|---|---|---|---|---|
| Inhaled ISO + Oral Ondansetron | Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral elixir comprising ondansetron (4 mg). Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes. Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47. | 0 | None | 0 | 40 | 0 | 40 | View |
| Inhaled ISO + Oral Placebo | Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir. Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes. Oral placebo: Subjects will drink solution comprised of 0.25 ml of Oral Sweet Sugar Free NDC 0574-0302-16 with 4.75 ml of sterile water for dilution NDC 0264-2101-00 | 0 | None | 0 | 40 | 0 | 40 | View |
| Inhaled Placebo + Oral Ondansetron | Inhaled normal saline pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir. Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47. Inhaled normal saline: Patients will inhale from normal saline pads as needed for nausea up to q30 minutes. | 0 | None | 0 | 40 | 0 | 40 | View |