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
Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-25 @ 12:56 PM
NCT ID:
NCT04006795
Description:
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
Frequency Threshold:
0
Time Frame:
Up to Day 40
Study:
NCT04006795
Study Brief:
A Photoxicity and Photoallergy Study of a Developmental Face Cream, Serum and Lotion
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Developmental Serum | All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing developmental serum (0.02 mL/cm\^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites were cleaned, developmental serum was re-applied and 1 of the 2 sites were irradiated with 2.5 J/cm\^2 UV A radiation,then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites were assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40. | 0 | None | 0 | 37 | 8 | 37 | View |
| Developmental Lotion | All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing developmental lotion (0.02 mL/cm\^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, developmental lotion was re-applied and 1 of the 2 sites were irradiated with 2.5J/cm\^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites were assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40. | 0 | None | 0 | 37 | 8 | 37 | View |
| Developmental Cream | All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing developmental cream (0.02 mL/cm\^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites were cleaned, developmental cream was re-applied and 1 of the 2 sites were irradiated with 2.5J/cm\^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites were assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.. | 0 | None | 0 | 37 | 8 | 37 | View |
| Negative Control | All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing 0.9 percent normal saline (0.02 mL/cm\^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, normal saline was re-applied and 1 of the 2 sites was irradiated with 2.5J/cm\^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites will be assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40. | 0 | None | 0 | 37 | 8 | 37 | View |
| Overall Participants | All participants in 3 week induction phase topically applied 2 semiocclusive patch (0.02 mL/cm\^2)on Monday, containing developmental serum,lotion,cream,negative control(NaCl: 0.9 %)at 2 sites on dorsum for 24 hours.Post patch removal (Tuesday) sites cleaned,developmental serum reapplied,1 site irradiated with 2.5 J/cm\^2 UVA radiation,then with 0.3 MEDs of UVA+UVB radiation.Duplicate test site not exposed to UVradiation. 24hours post irradiation(Wednesday),sites assessed,duplicate patches applied as on Monday.Irradiation on Thursday similar to Tuesday,assessment post 24 hour on Friday.Participants then entered 2 week rest phase(no product or patch applications) followed by challenge phase where all participants applied 2 semiocclusive patches at 2 naive sites for 24 hours, 1 site irradiated(like induction phase).Assessment done after 24,48,72 hours of irradiation till Day 40. | 0 | None | 0 | 37 | 8 | 37 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Herpes virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Vaginal discharge | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v21.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |