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 |
|---|---|---|---|---|---|---|---|---|
| Placebo | Placebo control SPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am. * Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \[this will be on a 1:1:1:1:1:1:1:1 ratio\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval. | 0 | None | 0 | 22 | 0 | 22 | View |
| Dose 1 | 1.5 g of omega-3 supplement SPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am. * Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \[this will be on a 1:1:1:1:1:1:1:1 ratio\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval. | 0 | None | 0 | 22 | 0 | 22 | View |
| Dose 2 | 3.0 g of omega-3 supplement SPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am. * Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \[this will be on a 1:1:1:1:1:1:1:1 ratio\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval. | 0 | None | 0 | 22 | 0 | 22 | View |
| Dose 3 | 4.5 g of omega-3 supplement SPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am. * Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \[this will be on a 1:1:1:1:1:1:1:1 ratio\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval. | 0 | None | 0 | 22 | 0 | 22 | View |