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 |
|---|---|---|---|---|---|---|---|---|
| 3-drug Standard Therapy | FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food) Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food) | None | None | 0 | 11 | 0 | 11 | View |
| 5-drug Experimental Therapy | FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food) Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food) Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food) Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food) | None | None | 0 | 23 | 0 | 23 | View |