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 |
|---|---|---|---|---|---|---|---|---|
| CSM Classic | All participants with evaluable data for CSM Classic vs P2 Control pairwise comparison. | 0 | None | 0 | 12 | 0 | 12 | View |
| P2 Control Standard (vs. CSM Classic) | All participants with evaluable data for CSM Classic vs P2 Control pairwise comparison. | 0 | None | 0 | 12 | 0 | 12 | View |
| CSM Strawberry Flavor | All participants with evaluable data for CSM Strawberry Flavor vs P2 Control pairwise comparison. | 0 | None | 0 | 10 | 0 | 10 | View |
| P2 Control Standard (vs. CSM Strawberry Flavor) | All participants with evaluable data for CSM Strawberry Flavor vs P2 Control pairwise comparison. | 0 | None | 0 | 10 | 0 | 10 | View |
| All Study Participants | Study participants were randomly assigned to receive a single topical application of 3 study treatments (ChapStick Moisturizer \[CSM\] Classic; CSM Strawberry Flavor; P2 Control Standard) or no treatment to 4 test sites on the back; 80 +/- 2 milligram (mg) product was applied to each 40 square centimeters \[cm\^2\] test site (2.00 +/- 0.05 mg/cm\^2). If there was space for only 3 test sites on the participant's back, only one of the two ChapStick products was evaluated. Test sites received a progressive sequence of timed ultraviolet radiation (UVR) exposures and were evaluated for erythema immediately after irradiation and 16-24 hours (hrs) later. A total of 14 participants were enrolled; up to 4 test sites on the back of each participant were randomized to treatment (2 test products, P2 Control Standard and 1 untreated site used to calculate MEDu). In total, 12 participants were treated with CSM Classic (12 test sites); 10 participants were treated with CSM Strawberry (10 test sites); 14 participants received P2 Control Standard (14 test sites). One participant was excluded from the final CSM Classic vs P2 Control dataset (invalid data: erythema in all sub-sites treated with the test product). | 0 | None | 0 | 14 | 0 | 14 | View |