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 | Participants received two tablets of placebo in the morning on Day 1. Participants then underwent segmental challenge at 2 hours after first dose wherein LPS was instilled into the right middle segment and saline control into the lingula segment of the contralateral side. The second dose of placebo was administered 10 hours after LPS and saline challenge. | 0 | None | 0 | 25 | 10 | 25 | View |
| GSK2798745 | Participants received two tablets of 2.4 milligrams (mg) GSK2798745 in the morning on Day 1. Participants then underwent segmental challenge at 2 hours after first dose wherein LPS was instilled into the right middle segment and saline control into the lingula segment of the contralateral side. The second dose of a single tablet of 2.4 mg GSK2798745 was administered 10 hours after LPS and saline challenge. | 0 | None | 0 | 22 | 7 | 22 | View |