Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-25 @ 1:21 PM
NCT ID:
NCT04749459
Group ID:
EG004
Title:
All Study Participants
Description:
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).
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
14
Other Number Affected:
0
Other Number At Risk:
14
Study:
NCT04749459
Results Section:
NCT04749459
Adverse Events Module:
NCT04749459